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Regional Head of Pharmacovigilance, Jpac
2 weeks ago
**Job Summary**:
The Regional Head of Pharmacovigilance JPAC is to lead the team (eg. Local Safety Officers) in the JPAC region and provides an oversight of PV deliverables from Distributors and Partners relevant to products marketed in the region.
He/She is to establish and maintain a robust and compliant vigilance process and procedures relative to safety of medicinal products, medical devices, biologics and cosmetics. This role reports to the Global Head of R&D Quality and Pharmacovigilance.
- Influence the strategic direction of the business ensuring Galderma Affiliates are aware of and compliant with legislation and regulations pertaining to Pharmacovigilance
- Ensure the receipt, processing and distribution of adverse event reports and incident reports for company products directly or by oversight of safety vendors, distributors and affiliates.
- Drive implementation of Pharmacovigilance regional processes and systems, in line with Galderma's policies and Global SOPs, and by working closely with EU Qualified Person Pharmacovigilance.
- Analyze, identify and resolve risks or issues to all the aspects of the regional product safety and activities are closely monitored to fulfil the regulatory requirements
- Reviews safety documents (eg. Periodic Safety Update Reports) intended for submission to regulatory agencies for renewal of marketing authorization approvals, new indications, or specific safety queries.
- Maintains inspection-readiness of the local drug safety office at all times.
- Remains current with global and regional Pharmacovigilance regulations and requirements, evaluate legislative changes affecting Pharmacovigilance, and develops strategies to support the patient safety at the local country level
- Lead and manage the Local Safety Officers, including financial aspects in collaboration to relevant General Managers.
**Job Requirements**:
- Degree in Pharmacy, Biology Sciences or Nursing
- 10+ years of experience working in Pharmaceutical Industries with at least 3-5 years of experience in a team management
- Sound knowledge of pharmacovigilance aspects
- Demonstrable familiarity with PV regulations and procedures required for submission to Health Authorities of the JPAC region for approval as well as regulations for collection, reporting and analysis of adverse events.
- Proficient with current computer technologies such as ARGUS or similar system
