MSI are working with a globally recognised pharmaceutical company to help soure an experienced Drug Safety Physician to join their team. The client is looking for someone with significant global safety experience, a strong academic record and clinical medicine experience.
To be considered for this position, you must have:
- Medical Degree (MD or MBBS)
- Experience working in clinical development safety
- Experience leading signal detection and risk management activities
- Experience working in hospital/clinical medicine
- Right to work in the USA
In this role, you will be responsible for:
- Work in cross-functional expert teams to develop or support proactive risk management strategies for assigned marketed compounds. Support development of risk management strategies for investigational compounds.
- Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
- Periodic Benefit Risk Evaluation Reports / PADERs
- Development Safety Update Reports
- Risk Management Plans
- Clinical Overview Statements
- Continuous monitoring and further development of the product safety profile
- Safety issue management
- Set-up of safety analyses in both post marketing and clinical trial databases
- Close collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studies
