Bayer AG is a German multinational pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world. Headquartered in Leverkusen, Bayer’s areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.
Name of Position: Regional Pharmacovigilance Officer
Location: Maharashtra
Division: Pharmaceutical
Job 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.
Roles 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
Qualification and Skills Required:
- 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
