Pharmacovigilance jobs in Hyderabad : Drug safety

[mskavi]

Novartis Healthcare Pvt. Ltd.
Building # 6, Raheja Mind Space,
Hitech City, Madhapur,
Hyderabad – 500081
INDIA

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Job ID 54722BR
Position Title Pharmacovigilance Expert
Division Pharmaceuticals
Business Unit General Medicines
Country India
Work Location India - Hyderabad
Company/Legal Entity India Novartis Healthcare Private Limited
Functional Area Development
Job Type Full Time
Employment Type Permanent

Job Description
Provide support to the Brand Safety Leader/Pharmacovigilance Leader (BSL/PVL) in the monitor-ing of the safety profile of assigned products including: Periodic Safety Update Report (PSUR), Risk Management Plan (RMP) updates and associated activities, safety signal detection, coordinat-ing the management of large datasets for analysis purposes , responses to external authorities, review of clinical protocols and other regulatory activities, and responsibility for the clinical review and evaluation of cases including input for follow-up and data cleaning, within agreed timeframes and to a high standard of accuracy, in compliance with IMS business rules, standard operating procedures and global and local regulatory requirements

1. Assist the BSL/PVL in monitoring the safety profile of product
2. Provide input into responses to inquiries from regulatory authorities or health care profes-sionals on safety issues
3. Provide input to responses for CPO requests involving safety issues
4. Assist in the development and updates concerning safety input to the core data sheet and the investigator’s brochure
5. Play an active role in standing and ad hoc Safety Management Team (SMT) meetings
6. Play an active role in SIGDET and MSRB meetings including preparatory activities
7. Assist with project activities on an ad hoc basis
8. Interfaces with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events, updating on PVO requirements
9. Provide clinical input to detailed review of events of interest for key data extraction for analysis purposes including the PSUR and other ad hoc analyses
10. Together with the BSL/PVL, co-author the PSUR including analytical input to PSUR for known and potential risks defined in the RMP
11. Assist in the development and maintenance of the RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures
12. Assist in the preparation of other safety documents, as required, including the Annual Safety Update Report (ASR) and the Investigator’s Brochure (IB)
13. Participates in review of clinical study protocols /reports/other regulatory documents as needed.
14. Provides support as required for licensing activities, regulatory authority inspections/audits and for project/product recall activities.
15. Lead the training and mentoring of internal and cross-functional team members
Minimum requirements Education (minimum/desirable): Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or MD
Languages: Good knowledge/fluency in English. Knowledge of other languages desirable.

Experience/Professional requirement:
- 4-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MD with 3 years clinical experience postdoctoral
- Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
- Excellent understanding of clinical trial methodology, GCP and medical terminology
- Attention to detail and quality focused
- Strong organizational and project management skills
- Strong negotiation and communication skills, and the ability to operate effectively in an international environment
- Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process
- Strong technical and problem solving skills
- Good presentation skills
- Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications.
- Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
- Ability to mentor, and coach within IMS and cross functionally
- Ability to lead global work groups
- Ability to lead and deliver initiatives

[mskavi]

Dr. Reddys Laboratories Ltd.. Hyderabad / Secunderabad : Pharmacovigilance

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Job Description:
Investigation of spontaneous AEs and AEs from clinical trials Organise Postmarketing Surveillance (PMS) studies and their reports.

Desired Candidate Profile:
Experience in monitoring AEs. Knowledge of Pharmacovigilance and regulatory norms

Dr Reddys Laboratories Ltd
Human Resources
Dr. Reddy's Laboratories Ltd.
Greenlands, Ameerpet
Hyderabad - 500 016
INDIA

Tel: +91 040 2373 1946
Email: talent@drreddys.com

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hi myself dr nitin pawar.my basic background is B.H.M.S.n post graduate diploma in pharmacovigilance.i m interested.please do reply

[Guest]

Sir i was working in hyderabad, Iam very much interested for this job pleae go through my resume once, waiting for possitive reply


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 projectsScitech 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)

[navakanth]

CURRICULUM VITAE


Navakanth. B Mail: bnavakanth AT gmail.com

Mobile: 09490213573

Objective:
Focus on a challenging career in an industry seeking a quality environment where my knowledge can be shared and enriched looking for the opportunity where I can improve my skills.

Personal Skills: Comprehensive problem solving abilities, Ability to deal with people diplomatically, willingness to learn, Team facilitator.

Area of interest:
Bioavailability & Bioequivalence
Pharmacovigilence
Clinical Research (Associate/Auditor/Coordinator)

Present status:
Working as a Assistant Professor in MITS college of pharmacy, kodada from July 2009 to till date
Academic project:
Project: Assessment of safety and efficacy of fixed dose combination of Glimeperide and Metformin in patients with type 2 diabetes mellitus.
Duration: 8 months.
Role: Trainee Clinical Research Coordinator
Organization: Mediciti Hospital, Hyderabad.

Software Skills:
Operating Systems : MS-DOS, Windows 95/98.
Office Tools : MS-Office 2007, MS-Excel 2007.


Conferences attended:
- Attended Indian pharmaceutical Congress (IPC) Programme held in Hyderabad
- Attended a National conference on ANIMALS WELFARE & ETHICS held in ANNAMALAI UNIVERSITY, CHIDAMBARAM.
References:
Dr. Naveen Chander Reddy M.D Dr. V. Parthasarathy M.Pharm. PhD,
Cardiologist & Clinical research Co-ordinator, Professor,
5-9-22, Mediciti Hospitals, Department of pharmacy,
Secretariat Road, Annamalai University,
Hyderabad-500063. Tamilnadu.

Personal Profile:
Name : B.NAVAKANTH
Father’s Name : B.SAMBASIVA RAO
Date of Birth : 05-05-1986
Sex : Male
Marital Status : Single
Nationality : Indian
Address : S/o sambasiva Rao
Attaluru (v)
Amaravathi (m)
Guntur (D)
Andhra pradesh-522436
Languages Known : English, Hindi and Telugu

Declaration:

I here by declare that the information furnished above is true to the best of my knowledge

Yours Sincerely,
B.NAVAKANTH

[sushmitha07]

CURRICULUM VITAE
E-mail:sushmithabphram AT yahoo.com

CARRIER OBJECTIVE:-
Seeking a challenging career where my skill set and synergy can be put to maximum use for mutual growth of the organization and myself working in diversified fields

EDUCATION QUALIFICATION:-

Examination School/college Board/
university Year of
passing Marks (%)
B.Pharmacy R.R.College of Pharmacy Bangalore. Rajiv Gandhi University of Health Sciences Bangalore. 2009 75%
Intermediate Narayana Jr. College Kurnool. Board of Intermediate
Education 2004 75%
S.S.C Visveswarayya Memorial High School Gadwal Board of Secondary Education 2002 78%


B.Pharm Final Year Project Details:
Training : Undergone industrial training
Duration : 2 months
Department : Production, stability.
Company : Dr.REDDY’S LABOURATORY,FTO II , BACHUPALLI ,
HYDERABAD.
Guide : Ch. Pavan Kumar
Senior executive, Dr.Reddy’s lab’s,
F T O II, bachupalli,Hyd.

Equipments handled:

- Tablet punching machine
- Capsule filling machine
- UV spectrophotometer
- Agilent HPLC 1100
- Pampas liquid particulate matter analyzer
- Brooke field Viscometer
- FTIR

Seminars Given :
1. Clinical research opportunities.
2. hospital formulary project.

Technical skill sets :
Diplama in computer Applications , hands on experience on computers, mainly with MS Office (MS Word and Power Point)
Suitability for your organization:

- Focused proactive Approach
- Good Communication Skills
- Punctuality
- Team Work
- Belief in self
- Confidence
- Positive Approach

Place:Gadwal
Date: 11-12-2009
(SUSHMITHA.M)

[ashwinkumar1706@yaho]

RESUME

ASHWINIKUMAR R. INGALE.

Career Objective:
Seeks an appropriate position for working with an organization having a strong vision & mission to enhance its growth & development providing simultaneous opportunities for strengthening the foundation of myself & further enhance my knowledge.

Educational Qualifications:-
- Post Graduate Advance Diploma in Clinical Research (PGDACR). Institute of Clinical Research of India , Andheri

- B. Pharmacy
(North Maharashtra University, Jalgaon) -2002 from Collage of Pharmacy, Faizpur with 57.40% in the final year.

- Diploma in Medical Laboratory Technology (D.M.L.T).-1998 From New Delhi with first class, first Rank.

- Diploma in Pharmacy
(B.T.E. Mumbai)-1997 from Institute of Pharmacy, Faizpur with 57.80% in the final year.


Additional Qualifications / Skills:
- MS-Office (Word, Excel, Power Point, Internet Concepts)
- FDA Approval in Tablets Manufacturing Section at Ajanta Pharma Limited, Paithan

Job Responsibility:¬ -
- Responsible for activities involved in the conduct of Clinical trial.
- Comply with company policies, SOPs & regulatory guidelines
- Ensuring that the source notes are according to the ICH-GCP requirements.
- Coordinating site initiation visits, submission of study protocols & other documents to ethics committee.
- Performing site drug accountability, checking that the study drugs are appropriately stored and dispensed, ensuring the drug dispensing records & temperature logs are up to date and monitoring expiry dates of study supplies
- To coordinate between local / central laboratory and courier for the shipment and collection of study material
- Update patient tracking log to the sponsor company
- Assuring adequate reporting of adverse events and ensuring that the collection of data from medical records, subject interviews, questionnaires, diagnostic tests and other sources are complete and reported accurately
- Follow established guidelines in the collection of study data and respond to study procedures/protocol questions
- Works closely with Project Manager, Sponsor’s CRA as appropriate, training & QC Managers, Medical associates
- Maintaining strict confidentiality about study protocol, study drug and study procedures & SOPs
- CRF (Case Report Form) completion
- Track the flow of regulatory documents for all projects responsible for in order to co-ordinate and deliver the appropriate regulatory documents to meet regulatory and Ethics Committee submission dates
- Assist Principal Investigator in patient selection and clinical research study
- Patient’s follow-ups
- Ensuring protocol complaints at the centre
- All other administrative support to the Principal Investigator

Work Experience:
- Worked as Production Executive (Coordinator) in Shalina laboratories Pvt. Ltd. Mar 2008 to sep 2008.
- Worked as Production officer in M.J. Biopharm. Pvt. Ltd Navi Mumbai from Sep 2007- Mar 2008.
- Worked as Jr. Production officer in Ajanta Pharma Ltd. Paithan Dist-Aurangabad. From Oct 2005 to Aug 2007
- Worked as Production officer in Khandelwal Laboratories Ltd Vapi (Gujarat), From Aug 2004 to Sep 2005.
- Worked as Trainee Production supervisor in Niramay Pharma Pvt. Ltd, Nashik, From Dec 2002 to Aug 2004.
Personal Details:-

Hobbies/Interests: Listening music, surfing internet, Traveling.

Date of birth: 17th June 1977
Nationality: Indian.
Gender: Male
Marital Status: Married
Languages: English, Hindi, Marathi

[mahendra.rokade9]

Respected sir
I am Mahendra Rokade, having educational background of M.Pharm and Diploma in Clinical Research and interested in this prefferd job, i am attaching my resume here

TO,
The Managing Director
Respected sir
I the undersigned had completed my post graduation (M.Pharm) in pharmaceutical chemistry from Nagpur University and Diploma in Clinical Research from Getwell Hospital Nagpur. Sir I am interested to work in your compony in clinical research organization in pharmacovigilance, drug safety, clinical data management, clinical research coordinator . Sir please take into consideration my this application for the post in your company and give me a chance to do my level best in your company.

Thanking you yours faithfully
Date- 31-jan-2010 Mahendra D. Rokade

Objective
Intend to play crucial role in creative research projects and make significant contribution in pharmaceutical field.
- Educational Qualification:
- Completed Bachelors Degree in Pharmacy from J. L. Chaturvedi College of Pharmacy with 59.0% (2007).
- Masters Degree in Pharmacy in J. L. Chaturvedi College of Pharmacy, Nagpur university.with 71% (2009).
- M. Pharm. Research entitled, “synthesis and pharmacological studies of mutual prodrug from Diclofenac with other NSAID”.under the able guidance of, Professor Mrs. A. J. Asnani; J. L.Chaturvedi College of Pharmacy, Electronic zone, Nagpur-441110.
- Research entitled “Simultaneous method development on combination of paracetamol and promithazine.”
- Diploma in Clinical Research from Academy of Ethical Clinical Research Institute ,GETWELL HOSPITAL, NAGPUR
- Work Experience
- Preclinical studies on prepared derivatives of diclofenac in research laboratories of J.L.Chaturvedi college of pharmacy, Nagpur
1) Anti-inflammatory studies by rat paw oedema method
2) Analgesic studies by acetic acid induced whrithing method
3) Ulcerogenicity studies by induced phenyl acetic acid method


- Additional Qualification:
- Training program on Intellectual property rights conducted by Govt. of India. (2008)
- Presentations:
- Poster presentation on “EMERGING TRENDS IN ADVANCED DRUG DELIVERY SYSTEMS” held on at Sharad Pawar College of Pharmacy, Nagpur, 2008.
- Poster presentation on “HIV-AIDS & HERBAL DRUG RESEARCH” held on at J. L. Chaturvedi College of Pharmacy, Nagpur, 2008.
- Participated in DTS Sponsored National Symposium”NANOTRENDS-2008” at Dharampeth M. P. Deo Memorial Science Collage, Nagpur
- Participated in Indian Pharmaceutical Congress 2009 at Delhi.
- Conference Attended:
- Emerging Trends in Advance Drug Delivery System Held at Sharad Pawar College of Pharmacy, Nagpur, 2007.
- Three days National Workshop on Coating Technology of Solid Dosage Forms, held at Gurunanak College of Pharmacy, Nagpur, 2008.
- Strength
- Confident
- Self starter
- Focused
- Quick learner
- Team player
- Personal Profile:
- Date of Birth: 30th June 1985
- Marital Status: Unmarried
- Language: English and Hindi, Marathi (Mother Tongue)
- Declaration
I Declare that the information furnished above is true and correct to the best of my knowledge and belief, and that no related information is concealed


Mahendra D. Rokade