Post: Sr. Regional Pharmacovigilance Officer
Job Description The Senior Regional Pharmacovigilance (PV) Officer plays a critical role within the PV Regional Center, ensuring compliance with PV Quality System Documents (QSDs) and global regulatory standards to safeguard patient safety. This position focuses on expert case management and PV process oversight to uphold Bayer’s Pharmacovigilance standards.
Tasks and Responsibilities
- Support for External Service Oversight: Assist the PV Regional Center Manager in monitoring activities managed by external service providers.
- Functional Support for Local PV Teams: Provide support for source document handling/upload in SDRA during team absences, and undertake additional country-specific tasks as needed.
PV Case Management:
- Handle PV cases and Product Technical Complaints (PTCs), including:
- Receipt and transfer of PV cases to Argus when applicable.
- Clarification of missing or unclear information in PV cases.
- Follow-up and management of action items.
- Coordination of PV case source document translations.
- Collaboration with Country Quality Function on PTC-related PV cases.
PV Process Management:
- Ensure high-quality oversight of PV processes:
- Management of PV QSDs.
- Assistance in local PV Corrective and Preventive Action (CAPA) management.
- Support in planning, execution, and coordination of PV trainings for local organizations and external partners.
- Management of Pharmacovigilance Contracts.
- Preparation for inspections and audits in collaboration with local PV teams and global inspection management.
- Compilation of Pharmacovigilance System Master Files.
Mentorship and Team Support:
- Mentor junior team members in daily operational activities within the PV Regional Center.
Candidate Profile
- Scientific degree in related field, with 3-5 years of experience in the Pharmaceutical industry, preferably in Pharmacovigilance.
- Experience leading teams in an international, multi-country environment.
- Proficiency in English (written and verbal communication).
- Strong team player capable of working under tight deadlines.
- Excellent organizational and problem-solving skills in complex environments.
- Ability to follow procedures and propose process improvements.
- Independent problem-solving ability and familiarity with data management concepts and systems.
Additional Information
- Experience: 3-5 years
- Qualification: Scientific degree related to the field
- Location: Maharashtra: Thane
- Industry Type: Pharma/Healthcare/Clinical Research
- Reference Code: 819525
- End Date: 10th July 2024
This position offers an opportunity to contribute significantly to Bayer’s Pharmacovigilance efforts, ensuring adherence to global standards and enhancing patient safety across diverse operational landscapes.
