SERM Prinicipal Physician

Scientific / Medical Knowledge PV Expertise :

Responsible for signal detection and evaluation activities for assigned products.

Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.

Assists in the production of Risk Management Plans (RMPs) / Risk Tables for designated products, in consultation with senior personnel.

Authors regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.

Acts as a member of a process improvement initiative team within GCSP.

Complete any post audit / inspection activities within the required timeline

Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues / problems, and makes decisions with consultation of SERM physician.

Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritize own workload with minimal guidance.