Affiliate Pharmacovigilance Coordination Manager
3 weeks ago
Parkside Recruitment is currently looking for an Affiliate Pharmacovigilance Coordination Manager.
The successful candidate will be tasked with the upkeep and development of departmental protocols, including but not limited to, Standard Operating Procedures (SOPs), while ensuring that the European affiliates receive adequate support in executing pharmacovigilance functions in alignment with SOPs and both regulatory and global standards.
KEY RESPONSIBILITIES
- Facilitates support for Affiliate Pharmacovigilance Coordination (APVC) activities
- Addresses or coordinates pharmacovigilance-related concerns with pertinent global or local departments for resolution
- Organizes and facilitates regular or on-demand training sessions or meetings with local and global pharmacovigilance teams
- Assists global pharmacovigilance teams in the rollout of new protocols, systems, and requirements
- Aids in the establishment of a compliant pharmacovigilance framework within the affiliates
- Monitors and enhances local pharmacovigilance systems in the affiliates
- Oversees relevant written pharmacovigilance protocols within the affiliates
- Reviews and contributes pharmacovigilance-related insights for Global Standard Operating Procedures (GSOPs) from the Local Safety Management (LSM) perspective
- Acts as a subject matter expert for APVC-related topics during pharmacovigilance regulatory inspections or quality assurance audits, and assists with deviations and Corrective and Preventive Actions (CAPAs) as necessary
- Ensures that all work is thoroughly documented and archived
- Supports, reviews, and performs quality control on assigned Pharmacovigilance System Master File (PSMF) Annexes, as applicable
- Serves as a liaison internally and with external pharmacovigilance service providers and business partners regarding drug safety and pharmacovigilance matters, as designated by pharmacovigilance management
QUALIFICATIONS/ EXPERIENCE REQUIRED
- Educational background in healthcare or life sciences (e.g., biological sciences, pharmacy, nursing, physician assistants, nurse practitioners) preferably at the bachelor level (or equivalent local degree) or higher
- A minimum of 3 years' experience in pharmacovigilance or a related field within the pharmaceutical industry or Health Authority
- Proficient in spoken and written English, with a solid understanding of English medical terminology
Strong knowledge of pharmacovigilance-related regulations is essential.
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