Description
The Pharmacovigilance (PV/安全性)業務 role is responsible for ensuring patient safety by collecting, evaluating, and implementing measures for GSK products. The role involves building and maintaining systems for collecting and evaluating safety information, managing outsourced services, and providing training to stakeholders.
Key responsibilities:
- Develop and implement end-to-end procedures for safety information collection, database input, and evaluation
- Manage outsourced services and provide guidance to vendors
- Provide safety-related training to internal teams, GSK Global, and partners
- Report safety information to regulatory authorities and partners
- Oversee compliance with regulatory requirements
- Collaborate with GSK Global to develop and improve processes
- Manage inspections by regulatory authorities and audits by Global or partner companies
Requirements:
- 5+ years of experience in pharmaceutical pharmacovigilance (PV)
- 3+ years of experience in individual case processing activities
- Strong understanding of PV-related regulations (GVP, GCP, GPSP)
- Excellent communication and collaboration skills
- Ability to work in English and communicate effectively with global teams
- Pharmacist license or degree in pharmacy
Preferred qualifications:
- Experience with Argus case processing
- Experience with automation technologies (AI, RPA) in pharmacovigilance
- Project leadership experience
- Negotiation skills with global stakeholders