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 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)

[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)