Job Description
Job Overview
The Assoc Manager, Safety Operations Team is responsible for leading and overseeing all local pharmacovigilance activities, ensuring compliance with regulations and best practices. This includes the implementation, management, and maintenance of the local pharmacovigilance system.
**Key Responsibilities**:
Oversight of Pharmacovigilance Operations:
- Monitor and oversee all safety-related operations and communication activities.
- Serve as the primary point of contact for the Sponsor (when applicable).
- Ensure efficient and accurate ICSR (Individual Case Safety Report) surveillance, including collection, reporting, and follow-up.
- Manage translation processes as needed.
- Author local case narratives for regulatory reporting as required by local authorities.
Support & Collaboration:
- Support local literature searches, reconciliations, and quality assurance activities.
- Assist with audit and inspection readiness.
- Collaborate effecti...
The Assoc Manager, Safety Operations Team is responsible for leading and overseeing all local pharmacovigilance activities, ensuring compliance with regulations and best practices. This includes the implementation, management, and maintenance of the local pharmacovigilance system.
**Key Responsibilities**:
Oversight of Pharmacovigilance Operations:
- Monitor and oversee all safety-related operations and communication activities.
- Serve as the primary point of contact for the Sponsor (when applicable).
- Ensure efficient and accurate ICSR (Individual Case Safety Report) surveillance, including collection, reporting, and follow-up.
- Manage translation processes as needed.
- Author local case narratives for regulatory reporting as required by local authorities.
Support & Collaboration:
- Support local literature searches, reconciliations, and quality assurance activities.
- Assist with audit and inspection readiness.
- Collaborate effecti...