Job Description
The Pharmacovigilance Scientist will support safety surveillance and signal management activities across clinical and post-marketing products. This role partners closely with PV Physicians and cross-functional teams to manage risk, contribute to regulatory deliverables, and ensure compliance with global pharmacovigilance requirements.
Key Responsibilities:
- Support product safety surveillance and signal detection activities
- Contribute to risk management plans (RMPs/REMS) and benefit-risk assessments
- Perform safety data analysis and author safety documentation
- Support aggregate reporting (DSURs, PSURs, PADERs)
- Provide PV input to clinical and regulatory documents
- Collaborate with cross-functional and vendor partners
Qualifications:
- Life sciences or healthcare degree
- 2–4 years of pharmacovigilance experience
- Experience with safety reporting and MedDRA
- Strong communication, analytical, and organizational skills