What are the responsibilities and job description for the Senior/ Director Clinical Safety Pharmacovigilance position at Innovent Biologics?
This role will lead the clinical safety pharmacovigilance (PV) activities within expected scope and timelines. The incumbent will play a major role in ensuring the safety pharmacovigilance deliverables and processes are followed and support the establishment and growth of PV functions to assure global capabilities and execution.
Key Roles & Responsibilities
- Lead clinical safety pharmacovigilance in conducting safety surveillance of assigned products.
- Prepare and manage the aggregate reports draft, finalization and submission timelines by working closely with CROs and relevant department contributors.
- Draft the safety sections of aggregate reports, IB, protocols, health authority responses, data management or safety management committee presentations and other similar activities.
- Accountable for the delivery of assigned tasks according to quality, time, budgets, and resources.
- Liaise with case processing team internally and CROs to ensure timely delivery of all case processing and health authorities’ commitments for PV safety.
- Partner with pharmacovigilance operations, clinical development and operations, regulatory and other functional areas for the successful implementation and execution of all PV commitments.
- Act as a safety pharmacovigilance resource in interactions with internal and external stakeholders.
Role Requirements
