PPD Pharmaceutical Development India Pvt Ltd Mumbai : Safety Specialist

[Rajkumargautam]

PPD Pharmaceutical development I Pvt Ltd. Mumbai : SAFETY SPECIALIST

Designation: Safety Specialist
Experience: 2 - 5 Years
Location: Mumbai

Job Description:
The Safety Specialist is responsible for the receipt and follow-up of serious adverse events (SAEs) and the
input of data into the safety database(s). He/she must maintain knowledge and understanding of PPD’s SOPs and
WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety
issues; and effectively interface with project teams, client company, and investigators regarding SAE activities. The
Safety Specialist may also get involved in the preparation of department SOPs and WPDs. He/she also
prepares for, and attends audits.

Desired Candidate Profile:
Familiar working with SOPs and WPDs
General awareness of ICH-GCP, Clinical Trial Directives, regulatory documents and safety issues
Capable of undertaking primary safety specialist role for specific projects.
Ability to prioritise workload effectively
Ability to work within team environment but also independently with supervision
Basic knowledge of working with databases
Good knowledge of MS Office (including Word, Excel and PowerPoint
Good oral and written communication skills
Ability to present SAE processes at investigator / sponsor meetings

Company Profile:
PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients

Website: http://www.ppdi.com

Keywords: SAE, Pharmacovigilance

[Singh Arvind]

ARVIND KUMAR SINGH
Mobile: 09891700662 ~ E-Mail: monushrinet@rediffmail.com

Seeking managerial assignments in Clinical Research Operations

CAREER PRÉCIS

- A result oriented M.Sc. (Biotechnology) with over 3 years’ experience in Teaching & Operations Management.
- Currently serving as Lecturer at Dehradun Institute of Management Science and Technology, Ghaziabad, U.P.
- Experienced in method development & validation.
- Adeptness in providing guidance and leadership to staff in accordance with specified program objectives.
- An effective communicator with excellent written & verbal communication abilities and strong analytical, problem solving & organisational abilities. Possess a flexible & detail oriented attitude.

SCHOLASTICS

2005 M.Sc. (Biotechnology) from Janardan Rai Nagar, Rajasthan Vidyapeeth University, Udaipur
2003 B.Sc. (Bio) from D.D.U. Gorakhpur University
1999 H.S.C. (Science) from U.P. Board, Allahabad
1997 S.S.C. from U.P. Board, Allahabad
EMPLOYMENT CHRONICLE

Jul’06/Present Lecturer at Dehradun Institute of Management Science and Technology,
Ghaziabad, U.P.
Dec’05-Jul’06 Instrument Engineer at Orochem Biotech, Delhi.

ROLE:

Teaching
- Conducting workshops, trainings on career planning, interview preparation & handling skills, GDs, transitions & other relevant topics.
- Recognising, respecting & nurturing the creative potential of each trainee and responding to all classroom queries in a spontaneous manner.
- Designing, developing and customising teaching curriculum for the students.
- Keeping records and writing reports on students’ performance.

Clinical Research Operations
- Independently managing, monitoring the investigative sites to ensure all the clinical trial activities conform to the protocol, all applicable guidelines, regulations, statutes and SOPs.
- Selecting sites and conducting study qualification visits for the purpose of assessing the site’s abilities to affectively conduct the trial as per the SOPs and study guidelines.
- Preparing proposals for sponsors.
- Conducting investigator meeting.
- Identifying and developing CROs and labs for clinical trials.
- Working within the provided budget and accordingly drafting letters of agreement with the sites.
- Monitoring clinical trial sites and preparing protocol/ investigator brochure/CRFs, ICFs, PMS.
- Ensuring proper storage, dispensation & accountability for clinical trial supplies at study site.
- Responsible for query handling and resolution, drug accountability and product management.

Documentation / Report Management
- Creating project specific documents & tools, tracking spreadsheets / databases, etc.
- Completing, producing and monitoring reports / brochures / SOP writings / information sheet / manuscripts requiring minimal corrections.
- Actively involved in writing and publishing trials reports.
- Monitoring & managing clinical trials such as multiple phases II, III, IV trials and PMS Studies.
CERTIFICATION

Certificate Course in Clinical Research & Data Management from Pune University, Pune with ‘0’ Grade.

PROFESSIONAL ENHANCEMENT SCHEDULES

- Microbiological (culture techniques), Biotechnological (Electrophoresis, Chromatography), Serological (Western blotting, ELISA, Dot Blot), experiments from Sugar Cane Research Station, Gorakhpur under the guidance of Dr. G.P. Rao, S.S.O, Sugarcane Research Station, Gorakhpur.
- Project at Hanuman Prasad Poddar Cancer Hospital & Research Centre, Geeta Vatika, Gorakhpur, U.P. Duration: 1 month.
- Training from Parag Dairy Centre, Gorakhpur. Duration: 1 month.
- Attended International Conference on Biomedical & Therapeutic Science.
- Attended National Symposium on Medicinal Plant.

IT SKILLS: MS-Word, Office & Internet browsing for literature and data searching.

PERSONAL DOSSIER

Date of Birth : 26th January 1983
Language Known : Hindi & English
Permanent Address : L.I.G. 16, Juhi Enclave Colony, Siktaur, Khorabar, Gorakhpur-273001, U.P.
Current Address : Flat No. 1B, Block- B12A, Dhawalgiri Apartment, Sector - 34, NOIDA-201301, U.P.

[sureshsingadi]

Dear H.R. Manager,

SUBJECT: To seek for the consideration in case of vacancies for a qualified and experienced clinical research professional in a firm of repute like yours.


Respected Sir/Madam,


By qualification I have completed Post Graduation in Pharmacy. I pursued my M.Pharmacy in specialization Pharmacology from Annamalai University, Chidambaram, and Tamilnadu
I have got 8 months experience as clinical research coordinator in Oncology project in NIMS and MNJ Institute of Oncology & Regional Cancer Centre, Hyderabad.
I wish to present my Curriculum Vitae to your kind notice.

I assure you that with my good communication skills and fast learning ability I would be able to perform the job on hand in the best possible way.

Hoping for favorable reply.

Thank you for your time and consideration.

Yours sincerely,
Suresh Singadi
sureshsingadi@gmail.com
Contact # +91 9912234156

[Narsimulu.G]

Dear H.R. Manager,

SUBJECT: To seek for the consideration in case of vacancies for a qualified and experienced clinical research professional in a firm of repute like yours.

Respected Sir/Madam,

By qualification I have completed Graduation in Pharmacy. I pursued my B.Pharmacy from S.S.R.College Of Pharmacy,Mahaboob Nagar.-Andhra Pradesh.
I have got 1 Year experience as clinical research coordinator in Oncology project in MNJ Institute of Oncology & Regional Cancer Centre, Hyderabad and Indo-American Cancer Institute and Research Center,Hyderabad.
I wish to present my Curriculum Vitae to your kind notice.

I assure you that with my good communication skills and fast learning ability I would be able to perform the job on hand in the best possible way.

Hoping for favorable reply.

Thank you for your time and consideration.

Yours sincerely,
Narsimulu.G
gnarsimulu26@yahoo.co.in
Contact # +91 9866216336

[artichandrakishore1]

I am intersted for the Job.

[GuestBG]

Dear Rajkumar,

I am having 2 years experience in Clinical Research, Currently working for a leading Pharmaceutical Company.

Qualification: M.Pharm (Pharmacology & Toxicology)
Exprties/ Experience:
In short;
Reporting and doing follow-ups of Adverse events from Clinical Trials/ Post Marketting Surveyance/ Spontaneous Reports/ Literature REports.
Event Coding using MeDRA,
Narrative writing,
Drug coding using organization/ WHO dictionary,
Assessment of seriousness of events, interpretation of lab data,

Query: Do you have openings for the night shift? If yes kindly let me know, I am very much interested for. Also let me know the timings.

Thank you, waiting for the response.

[Guest]

Dr. SANDIP KISHOR GURMULE
B.A.M.S., MSc Pharmaceutical Medicine
C/o Shobha Dongre, METRO-A, Building, Flat No-202, Kasturba Gandhi Nagar, Worli Mumbai-18
Contact No: 9423404711; E-mail: skgurmule AT gmail.com , skgurmule AT hotmail.com

ASPIRING CLINICAL RESEARCH PROFESSIONAL
Seeking entry level position in Clinical research/ Pharmacovigilance/Regulatory affair, Clinical Trials with a renowned Company, where I can utilize my credentials while providing opportunities to amalgamate personal enrichment with professional goals

PROFILE
- A qualified Master of Science with specialization in Pharmaceutical Medicine & a post Graduate Diploma Pursuing in Intellectual Property Rights backed with a B.A.M.S degree keen to carve a niche in the area of clinical research.
- Familiar with GCP (Good Clinical Practice), GLP (Good laboratory practice), GMP (Good Manufacturing practice). Intrinsic knowledge of Phase 1, 2, 3, 4 trials. Keen learning ability to grasp new information and apply the same in a resourceful manner. Meticulous attention to detail and ability to meet strict deadlines.
- Undergone live project training in clinical research in Seth GS Medical College and KEM Hospital Mumbai. Having wide project exposure across Clinical research and Regulatory affairs, Pharmacovigilance at zonal Pharmacovigilance center & Patient’s safety and ethical issues related to clinical research.
- Well equipped with knowledge of International guidelines including FDA, ICH -GCP with ICMR, Schedule-Y, CIOMS, EMEA, Guidelines & proficient in Designing Protocol, CRF and ICF-PIS.
- Flexibility, resourcefulness and ability to work cohesively as part of a multidisciplinary team. Demonstrated problem analysis/ resolution skills, ability to solve problems quickly & completely.
- Possess excellent communication and interpersonal traits with talent for problem solving through reasoned thought processes.

Core Competencies
- Clinical Research and Pharmacovigilance - Protocol Development - monitoring trials - Conducting Feasibility studies - Strong Interpersonal Skills - Training and Development - Excellent communication

EDUCATION & PROFESSIONAL CREDENTIALS
Master of Science (Pharmaceutical Medicine) YEAR 2009
University Department Of Interpathy Research Technology
Post Graduate Diploma in Intellectual Property Rights pursuing
IGNOU

B.A.M.S YEAR 2006
R.T Ayurved College, Akola
Memberships:
- Student member of American College of Clinical Pharmacology (ACCP)
- Acknowledged as Life time member of National Integrate Medical Association (NIMA)

Computer Skills:
MS Office, C.C.C.O & Internet Skills

ACADEMIC PROJECTS & SEMINARS ATTENDED
- Completed Project on Rheumatoid arthritis in Department Medicine of Seth GS Medical College and KEM Hospital Parel Mumbai.
- Completed a one year project on ADR Monitoring in Zonal Pharmacovigilance center in Department Medicine of Seth GS Medical College and KEM Hospital Parel Mumbai.
- Done a project on Prescription Monitoring For Acute Febrile Illness in K.B.BHABHA Hospital, Bandra
- Successfully completed an open label, observational, comparative study of safety, efficacy of Telmisartan in comparison with Losartan in patient of mild to moderate Hypertension in Indian population.
- Attended an international conference on “Contemporary issues and challenges in Drug Development” Organized by South Asian Chapter of American College of Clinical Pharmacology (ACCP) & Department of Clinical Pharmacology, Seth G. S. Medical College and KEM Hospital, Mumbai, 5th - 7th October 2007 at Mumbai, India.

EXTRA CURRICULAR ACCOLADES
- Participated in “Avishkar- intra University championship at inter university championship at Nasik”
- Participated in college debate on – “Patents protection for pharmaceutical products are “good” for India”
- Actively participated in arranging the one day conference on “Research Methodology” and work as a Group Leader of advertising committee for the conference
- Achieved 1st Prize as a “face of the year” in collage festival

Date of Birth: 28th June, 1983
Language Proficiency: English, Hindi & Marathi
Passport Number: H1504608
Hobbies & Interest: Reading, Music, Traveling
Permanent Address: Plot No.795, New Nandanwan, Trimurti Chauk, Nagpur-440009
Reference: Dr. Pradip Awale
Associate Professor Infectious Disease Department.
KEM Hospital, Mumbai

[kanchan.navale]

KANCHAN P. NAVALE
kanchan.navale AT hotmail.com

OBJECTIVE:
To achieve a challenging and meaningful position to utilize my skills as a clinical research professional for the development of an organization, as well as to excel in my professional career

EDUCATION:
Master of Science in Pharmaceutical Medicine (M.Sc.Pharm.Medi.)
(Clinical Research)
2007 - 2009 University Department of Interpathy Research and Technology, MUHS, Nashik, Maharashtra, India.
Appear in 2009.

Bachelor of Pharmacy
2001 - 2004 N.D.M.V.P College of Pharmacy, Nashik, Maharashtra, India.
Graduated with a Higher second class in 2004.

JOB PROFILE:
Designation: Quality Control Officer

Organisation :
1) Vital Healthcare Pvt.Ltd. ISO
9001:2000 & WHO-GMP Pharma
Company in Nashik.
Tenure of work: Jan. 2005 to Nov 2006
Job Profile :
- Sampling & Testing of Raw materials.
- Instruments handling & calibration of
UV Spectrophotometer, Potentiometer,
Karl Fischer titrator, Polarimeter, pH
meter, MP/ BP apparatus, FTIR etc.
- Testing of water (Soft water, DM
water, WFI & Potable water).
- Preparation of Primary standards &
Working standards.
- Documentation: Routine QC
documents related to ISO & WHO-
GMP.
- Preparation of Specifications.
- Preparation of Quality plan &
Protocol's.
- Personal validation
- Awareness of ISO & WHO-GMP.

Technique Known:
- UV / Vis. Spectrophotometry
- Karl Fischer
- Potentiometry
- Polarimetry
- FTIR
- Thin Layer Chromatography

Designation: Quality Assurance Executive
2) VHB Life Sciences Ltd., Belapur,
Navi Mumbai.
Tenure of work: Mar. 2007 to June2007.

Job Profile :
- Collection of technical document & other
certificates required for registration
- Checking & finalization of technical points
mentioned on packaging materials.i.e.Art
work checking.
- Preparation of specification

CLINICAL TRIAL AND RESEARCH EXPERIENCE:
Study on “Amiodarone-induced Thyroid Dysfunction in Patients with Cardiac arrhythmia at K.E.M. Hospital, Mumbai ( Dec’08 to May ’09)
Study on “Rational use of antibiotics in hospitalized pediatric population at the civil hospital, Nashik. (Jun ’08)

ADDITIONAL QUALIFICATIONS:
Knowledge of
- GMP guidelines.
- ICH-GCP guidelines.
- WHO guidelines.
- Schedule Y guidelines.
- Various regulatory guidelines.

CONFERENCES ATTENDED:
Participated in “Workshop on Pharmacovigilance” arranged by IDD, K.E.M. Hospital, Mumbai. (March 2009)

OTHER ACTIVITIES:
Arranged workshop on “Research Methodology” for PG students of Ayurveda, Homoeopathy & Unani in March 2009 at Haffkin’s institute Mumbai.

Date:
(Kanchan Navale)

[shwetav]

Email: shweta.vartak17 AT rediff.com
Shwetavartak17 AT yahoo.com

CAREER OBJECTIVE:
To be a competent and able professional in the field of pharmacy or clinical research and contribute my best in terms of knowledge, dedication and hard work using my potential and creativity to the fullest.
ACADEMIC QUALIFICATIONS:

COMPUTER PROFICIENCY:
* Microsoft Office
* Internet Applications
* HTML
* JAVA
* Visual Basics

PROFESSIONAL EXPERIENCE:
Current Employer
SIRO Clinpharm Pvt. Ltd.
DIL Complex, Ground Floor,
S.V. Raod, Nr. Tatwagyan Vidyapeeth.
Ghodbunder Road Thane (W) 400 607

Designation
Executive-Drug Safety Associate

Tenure : 09-Jun- 2008 - till date

Safety Monitoring Experience in following projects:
1) An Open-Label, Dose-Finding, Prospective, Multi-Centre, Randomized, Parallel-Group Study in Breast Cancer Patients at High (>20%) Risk for Chemotherapy-Induced Severe Neutropenia
2) A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety in Patients with Previously Untreated HER2 Positive Metastatic Breast Cancer
3) A Phase II, 12-week, randomized, double-blind, parallel group, in patients with type 2 Diabetes mellitus.
4) A randomized, phase III, controlled, double-blind, parallel-group, multicenter study in patients with active rheumatoid arthritis.
5) An open-label randomized multicentric phase III study in patients with HER2 positive advanced gastric cancer.
6) A Phase 1/2 Study of in Subjects with Solid Tumors and Breast Cancer.
7) A Multicenter, Double-Blind, Randomized, Active-Controlled Study in HIV-Infected Patients.
8) A Multicenter, Randomized, Double-Blind Study in Patients with Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control.
9) A Dose Tolerability and Efficacy Study in Metastatic Pancreatic Cancer.
10) Dose Ranging Effects of Three Low-doses of IP on Glycemic Control and Safety Over Six Months in Subjects with Mild Type 2 Diabetes Mellitus Under Control with Diet and Exercise.
11) A Phase 3 Safety and Efficacy Study For Three Ophthalmic Intravitreal Injections for Inducing Posterior Vitreou Detachment in Retinopathy Subjects
12) A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with IP in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome.

Safety monitoring tasks performed:
· Data entry, Event causality assessment, narrative, CIOMS generation on AERS Database
· Serious Adverse Event Reporting; reviewing of SAE form for legibility and completeness, reporting of initial occurrence of an SAE, its follow up information to the sponsor and to Drug Controller General of India.
· Preparation of narrative for SAEs.
· Expedited SAE reporting: Submission of CIOMS and clinical analysis letter to DCGI and other participating sites within the timelines of schedule Y.
· Follow up with CRA’s for Ethics Committee acknowledgements.
· Preparing and updating trackers for SAE’s, Expedited SAE’s. EC and DCGI acknowledgements.
· Preparation of SAE management activity notes.
· Preparation CIOMS AND CLINICAL ANALYSIS LETTER AND EC template.
· Preparation and Submission of Periodic SAE listings to the participating sites and DCGI.
· Attending Telecon

TRAINING:
Jul, 2008
Training on ICH GCP at SIRO
Apr,2009-May,2009
Training on AERS Database
Aug, 2009
Training on Pharmacovigilance guidelines i.e. Volume 9a

[unregister]

CURRICULUM VITAE

SHARMISTHA DEB
E-mail: sharmistha_py AT rediffmail.com

CAREER OBJECTIVES:
Inculcate on scientific technology & research skills & expertise, to enhance my potential and vision for future & understand the impact of future corporate trends. Ready to accept any type of hardest work challenge. To achieve the goal in scientific research.

EDUCATIONAL QUALIFICATION:
Qualification Institute University / Board Year of passing Percentage

M.Pharm
(Pharmacology) PES College of Pharmacy, Bangalore
RGUHS, Bangalore 2007-08 80.34 %
( Topper)
Gold Medalist
B.Pharm PES College of Pharmacy, Bangalore
RGUHS, Bangalore 2005 70%
Silver Medalist
II P.U.C RGMCJS , Assam ASHBE, Guwahati 2000 59%
Class X Shishu Mandir School SEBA 1998 68%
Pursuing MBA from IGNOU (MUMBAI)

PROFESSIONAL EXPERIENCE:
(M Pharma Goldmadelist with industrial exposure in Clinical trials AND preclinical trials)
Currently working with SCITECH PATANT ART as Knowledge Scientist.

Reason for change:
I wish to relocate.
Due to family problems.

EXPERIENCE AND INTERNSHIPS:
150 hours training in Biocon Ltd (QC and QA department).
11 month experienced as project trainee in NRPL Pvt. Ltd. Bangalore.
5 month experienced in e-learning schedule.
1 year experienced as knowledge scientists in SciTech patent art Hyderabad (presently).
Brief description of experienced:
The various project I worked:
1. Preclinical projects (Natural remedies pvt ltd from may 2007-april 2008)
ANTI-DIABETIC AND ANTI-OXIDANT EFFECTS OF EXTRACTS OF LAGERSTROEMIA SPECIOSA ON STREPTOZOTOCIN INDUCED DIABETES MELLITUS” (11 month experienced as a project trainee in R& D of NRPL PVT LTD)
1. Anti-diabetic activity of NR-1 & NR-2 extracts. Natural Remedies Pvt. Ltd, Bangalore
2. Acute toxicity study of different extracts.(connexious life sciences, Bangalore)
3. Immunomodulatory activity of some specific extracts.
4. Anti –diabetic & Hypolipidemic activity of specific extract.
5. Anti-oxidant activity of some specific extracts.

CO- ADMINISTRATION OTHER PROJECTS:
1. Anti-inflammatory and analgesic activity of herbal extracts
2. Immonomodulatory activity of herbal extracts
3. Hepato-protective activity of herbal extracts
4. Acute and chronic toxicity study of in-house products
5. anti-anxiety activity of herbal extracts
6. anti-diahorrial study
7. Hypolipidemic study
8. Invitro study on prostaglandin receptors
9. AMES test for mutagenecity study
10. Micro-nucleus test for mutagenecity study
11. ADME study of drugs
12. Different enzymatic study
2. Clinical projects:(Scitech patent art 2008 june-2009 under Cerner life science)
Meta static breast cancer
Rheumatic arthritis
Gastric carcinoma
Statin
Diabetic activity
Job profile: Qc and Qa of article, preparation and validation of protocol, Reporting outcome and adverse events.
- Clinical research phases.
- Knowledge of ICH-GCP, US-FDA and Schedule Y.
- New drug application (NDA) & Investigational new drug (IND)
- Good understanding of Pharmacovigilance.
- Data Capture & Data Validation,
- Completing and Preparing Monitoring Reports / I.B. / SOP Writings/ Drug Accountability Form/ Periodic Visit Checklist/ Inform Consent Form/ Case Report Form/ Protocol Writing/ Source Data Verification.
- Knowledge of Outsourcing in Clinical Research, Ethics Committee, Study Feasibility & Site Selection, Site Initiation Visit, Patient Recruitment & Retention, Business Development in Clinical Research & Investigator Meeting.

Areas of Interest
- Pharmacovigilance
- CRA
- Medical Writing.
3. INTELLECTUAL PROPERTY RIGHT PROJECTS (Patenting)
1. INFANT FOOD (Analysis)
2. ANTI AGING (web searching)
3. Urinary catheter

Job profile: Searching, analysis, mapping.
Current CTC: 2.20000
Expected CTC: Negotiable
Notice period: As early as possible
ACHIEVEMENTS:
- Awarded silver medal for distinction in B Pham final year & gold medal in m-pharm for class topper.
- 8th rank in PGCET entrance test.
- Winner of sports in college level.
SEMINARS AND WORKSHOP ATTENDED:
1. Drug design and Pharmacogenomics, 15th June 2006 PESCP, Bangalore
2. Work shop on Research methodology, 8th Jan 2007 PES institute medical science and research Kuppam, Andhra Pradesh
3. National seminar on recent trends in drug design and discovery, November 30th 2007 PESCP, Bangalore.

PRESENTATION:
1. Presented journal club in Anti-diabetic activity of Shilajit extracts.
2. Presented journal club in anti-ulcer activity of Bauhinia speciosa.
3. Standarisation of streptozotocin induced diabetic models.

SKILLS AND TECHNIQUES KNOWN:
1. Handling of animals mice, rat, guinea pig, and rabbit.
2. Different methods of blood collection retro orbital bleeding, tail vein, cardiac puncture tail cut method
3. Instrumentation knowledge
- Semi-auto analyzer
- Micro-plate reader
- UV spectro meter
- Ph meter
- Electronic microscope
- Polyrite
- Thermostat
- Homogenizer
4. Basic computer knowledge/ MS-office tool

INTERESTED WORK AREA:
Clinical trial, preclinical area, regulatory affairs and patenting, research analyst .

HOBBIES AND INTERESTS:
Reading, Writing, Painting & Travelling.

PERSONAL PROFILE:
- Father’s Name : Late Himangshu Bhusan Deb
- Age : 24 years
- Languages known : Bengali, Hindi, English
- Nationality : Indian

I hereby declare that the above statements furnished are true to the best of my knowledge.

Date:
Place:Mumbai (SHARMISTHA DEB)

[Guest]

Would like to apply for the post of SAFETY SPECIALIST in your organisation. I would kindly request you to consider my CV if appropriate for the post. I am enclosing my CV here by.

Sir/Madam,
I wish to apply for an appropriate position in your Organization. I have studied Bachelors Degree in Pharmacy from the Dr.MGR Medical University, Chennai. My keen interests are in the domain of Clinical Research & Pharmacovigilance.
I pursuied training from Variety Pharmaceuticals to realise and build many of my key skills and abilities in the field of quality control.
I pursuied PG diploma in Pharmacovigilance at Clinical Research Education and Management Academy (CREMA) Bangalore,my performance reflecting my commitment to excellence and my dedication.
I owe my consistency and success to qualities that I possess such as being ambitious, persuasive, goal oriented, analytical and enthusiastic with a strong urge to proving myself in my chosen field.
I seek to imbibe the company’s values in my work culture and combine my key interests and competencies contributing towards the company's growth.
The testimonials of my educational qualifications are attached here with in my CV. I am confident that they adequately reflect my competencies to contribute towards the progress of your organisation.

Thanking you in anticipation of a favourable response.
Regards,

Name :MYDHILY.T.R

Objective
Person who wants to pursue a challenging career which makes use of own abilities than facilities value in addition to the organization using self knowledge, and also help grow along with the organization.

Profile
>Pursuied training in Field of Quality Control.
>Pursuied PG Diploma in Pharmacovigilance.

Key Skills
- Good Communication skills
- Good interpersonal skills
- Ability to adapt and work flexibly in a new domain.
- Comfortable to work in shifts.

Work Experience
Pursuied training from Variety Pharmaceuticals in the field of quality control.

Internship
Variety Pharmaceuticals: Pursuied experience in Quality Control.

Computer Skills
Applications: - MS Office Suite (MS Excel, MS Word & MS PowerPoint etc).
Internet Surfing.

Education
1)Bachelor of Pharmacy
College Name Year
KMCH College of Pharmacy, Coimbatore 2004-2008
2)PG Diploma in Pharmacovigilance from CREMA ,Bangalore.
*Interested in Case Handling Process in Pharmacovigilance (Case receiving ,Triage ,Process ,Review & Complete).

Project
Synthesis, Antimycobacterial & Antimicrobial screening of some Novel Cinnoline Derivatives.

Certification and Accreditation
* Attended National Level Seminar on "THE ART OF SCIENTIFIC WRITING" in the year 2008,at KMCH College of Pharmacy.
* Attended National Level Seminar on "RECENT ADVANCES IN PHARMACEUTICAL SCIENCES" in the year 2007, at KMCH College of Pharmacy.
* Attended National Level Conference on"TECHNOLOGICAL ADVANCES IN PHARMACETICAL SCIENCES" in the year 2005 ,at KMCH College of Pharmacy.

Interests and Activities
o Read books
o Travel
o Watch Movies and Listen to Music
o Play Violin
o Draw

Declaration:
I certify that the above mentioned details are true & I will fulfill my obligations to the organisation effectively and efficiently.
Thank you
In all sincerity,

Mydhily.T.R

[Guest Poster]

Hi,i m Graduate in BHMS, with Post grduate diploma in Pharmacovigilance, having 2 yr clinical experience. If any suitable job for me then plz reply.
regards,
Dr. Shailendra
9960912313

[sushilraut]

Key Interest :
Clinical Research

Raut Sushil Yadaorao
Address :
Permanent :Adyalwale layout, plot no84, Umrer, Dist- Nagpur, M.S.
Personal details :
Date of Birth : 01.03.1984
Contact No. :
09623603800
,07116-243442 (Home)

Blood group : AB +ve
Height : 173 cm
Weight : 55 Kg

Gender : Male
Marital status : Single
Nationality : Indian
Email ID :
Sushi.raut01 AT rediffmail.com


Curriculum Vittae
Objective :
M. Pharm qualified professional with well exposure of reputed pharmacy college wants to work in the area like clinical research where I will utilize my Analytical as well as Pharma knowledge for growth of organisation.
Educational background :
B.PHARM.
From I.P.E.R., Wardha. {University R.S.T.M, Nagpur, Maharastra } First class in June 2007.
M.PHARM (Pharmaceutics)
From N.E.T. Pharmacy college, Raichur,(Rajiv Gandhi University of Health Sciences, Banglore)
Sr. No Marks obtained Class Year
B.Pharm - styear 61.81% First June2004
B.Pharm II nd year 60.27 % First June2005
B.Pharm III rd year 57.81 % Second June2006
B.Pharm final year 63.36 % First June2007
M.Pharm - st year 71.33% First May 2008
M.Pharm- nd year 74.00% First May 2009
Experience :19 months in academics. Presently working as lecturer at Sharad Pawar College of Pharmacy (formerly N.C.P. Nagpur), Nagpur.


Software exposure :
Windows 98,
2000 professional, D.I.T Well versed with internet..

Address :
Correspondence :
N.E.T.Pharmacy College, Raichur, Karnataka, India.

RESEARCH PROJECT IN ” FORMULATION AND EVALUATION OF MICRO-EMULSION BASED ORGANOGELS FOR TRANSDERMAL DELIVERY OF ZIDOVUDINE”.
Skills achieved in :
- Testing of drug products like Tablets and capsules includes
i) In vitro drug dissolution/diffusion testing
ii) Water Content
iii) Disintegration
- Stability study testing at different stability intervals.
Extra curricular activities :
- A short term project in “ORODISPERSIBLE TABLET”
- Certificate in INTELLECTUAL PROPERTY MANAGEMENT.
- Have attended the Indian Pharmaceutical Congress 2006-2007 held at Mumbai.
Publications :
Communicated to International journal.
Posters : 1) Recent advances in oral mucosal drug delivery system.
2)Patient reliable dosage form
3) HPLC : A novel analytical tool.
First national convention on recent advances in pharmaceutical sciences & dug delivery 22-23rd Nov 2009, at K.N.Pharmacy college, Butibori

Supportive activities in the Audits like
Scout and Guide,
NSS,

Languages known :
English, Hindi, Marathi
Industrial tranning: Nulife Pharmaceuticals, Pimpri, Pune.

Hobbies:
Reading, and painting
References:
Dr .P G. Yeole
Principal,
I.P.E.R., Wardha
Dr. H. Doddayya,
Principal,
N.E.T. Pharmacy College Raichur, Karnataka

Instruments Handled:
1) Malvern zeta sizer(nano zs)
2) FTIR
3) Trinacular Optical microscope
4) HPLC (Agilent,Shimadzu,Dionex,Thermo )
5) UV spectrophotometer (Shimadzu)
6) Dissolution Tester (Electro lab, Lab India)Auto
&Mannual
7) Disintegrarion tester (Electro lab)
8) Hardness tester ( Erveka)
9) Friability tester ( Electrolab)
10) Brookfield viscometer(DL- version)
11)Fran and Kesharys diffusion cell.
12) pH meter.
Other responsibilities
I) Calibration of Instruments Like
1) HPLC (Agilent & Chromoleon –Dionex)
2)UV spectrophotometer
3) Dissolution Tester (Electrolab)
Personal Attribute:
I believe in responsibilities & commitment. I am hardworking & dedicated towards the work.
I sincerely hope that I will get a chance to prove my words.

Mr. Raut Sushil Yadaorao

[Guest]

Hello,
I am B-pharm graduate having additional qualification of Post graduate diploma in Clinical Research. I am working as Quality assurance co- ordinator from five months. Please let me know,if there is any vacancy in clincal data managment.

Regards,
Supriya