about 1 month ago
Hamlyn Williams has partnered with a global pharmaceutical company that is at an exciting stage with some game-changing products in Oncology & Neurology. This role would be as a Global Safety Scientist on a long-term contract, working closely with the safety physicians on safety evaluation, risk management aggregate reports and submissions.
The role involves but isn't limited to:
- Support the Benefit and Risk activities including signal detection, risk management, mitigation plans, safety analyses in aggregate reports.
- Review/provide input to Development Safety Update Reports (DSURs) and Aggregate Reports (PSUR, PBRER).
- Contribute to answers to safety-related questions from Regulatory agencies.
- Validate safety signals based on the review of single cases and aggregate data and escalate as appropriate during ad-hoc safety meetings.
- Support the safety physicians on the safety submissions
This is a home-based role so is a great opportunity for an experienced PV Scientist to expand their skillset.