Regional Pharmacovigilance Officer

5 days ago

Thane, India Bayer Full time

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Regional Pharmacovigilance Officer**

**POSITION PURPOSE**:
The Regional Pharmacovigilance Officer position belongs to the PV Regional Center. The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management, PV process management as well as PV benefit risk management activities. The Regional PV Officer contributes to assure patients’ safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements. The Regional PV Officer is also responsible for supporting administrative tasks for the PV team within the regional office.

**YOUR TASKS AND RESPONSIBILITIES**:

- **PV Case Management**:Handles all matters regarding PV cases/Product Technical Complaint (PTC) handling relating (but not limited) to:

- PV case receipt and transfer to Argus where applicable
- Identification of PV cases where missing or unclear information is provided and performs clarification as needed
- Coordination of translation of PV case source documents
- PV case data entry in Argus Safety Database, where applicable, as well as perform quality control of PV cases
- Liaises with the Country Quality Function in relation to PV cases associated with PTCs and aligns on actions
- PV case reconciliation with internal and external partners
- Reporting of PV cases to Health Authorities, Investigators and Ethics Committees where applicable
- **PV Process Management**:Supports PV process and compliance management by:

- QSD management for local PV teams
- Assisting local PV CAPA management
- Supporting preparation, roll-out and conduct of PV trainings given to local organizations
- Supporting local Pharmacovigilance Contract Management
- Supporting inspection and audit preparation in collaboration with local PV teams and global inspection management
- Supporting generating local Pharmacovigilance System Master Files

**WHO YOU ARE**:

- Scientific degree or other relevant qualification related to the area, with 3-5 years’ experience in the pharmaceutical industry
- Good English language (written and verbal communication)
- Team worker, able to work under tight timelines
- Good communication skills
- Good organizational skills
- Ability to follow and adhere to procedure

**Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.**

**YOUR APPLICATION**

**Location**:

- India : Maharashtra : Thane**Division**:

- Pharmaceuticals**Reference Code**:

- 794067**Contact Us**
- + 022-25311234

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