Manager - Pharmacovigilance - Bangalore

Manager - Pharmacovigilance - Bangalore

1 Nos.
5776
Full Time
10.0 Year(s) To 15.0 Year(s)
0.00 LPA TO 0.00 LPA
Job Description:

Job Description

 

2. Responsibilities & functions:

§  Management of local pharmacovigilance unit, including operational and compliance aspects, personnel development/training needs, processes and systems of the PV subunit.

§  Participation in and consultation on preparation and presentation of proposals

§  Management of contracted services within the area of responsibility on a project basis regarding quality, timelines, costs, etc. in the PV subunit, in alignment with the operational project management

§  Pharmacovigilance & drug safety, in alignment with the Global Head of PV

–      Clinical trial related PV (safety management plan, SAE-reporting and assessment, case narratives)

–      Writing and distribution of aggregate reports (PSUR, DSUR)

–      Post-authorization PV

–      Safety risk management planning

–      Risk analyses, signal detection

–      Specific safety studies (PASS, PMS, etc.)

 

3. Qualifications & competences:

§  Scientist, Medicine Doctor

§  Preferable: Special degree (certificate) in a clinical specialty or other relevant field of medicine, and/or substantial practical experience in a clinical setting.

§  Substantial practical experience in drug development, regulatory procedures and pharmacovigilance / drug safety

§  Substantial experience in planning, conducting, supervising and evaluating clinical trials

§  Ability to familiarise oneself with new scientific and medical areas and therapeutic area specifics as per demand within short periods of time.

 

 

4. Internal relations:

Liaises with internal and external groups to foster open communication related to the development and conduct of medical services and pharmacovigilance, strategy development, business planning and problem resolution.

§  PV has very close relations to COP and CDM / Biometrics management

§  PV has very close relations to the BD, proposal and contract management

 

 

 

5. External relations:

Liaises with external groups including industry associations and regulatory bodies to foster effective communication relative to the development and conduct of pharmacovigilance, strategy development, business planning and problem resolution.

§  PV establishes close contacts to all EA subsidiaries, subcontractors and partners. In particular, the department PV will initiate, coordinate and train global networks to apply professional medical and drug safety services in a team effort to respective multinational and global trials

§  PV cultivates project- and functional services-related contact to clients.

 

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