Job Summary
A company is looking for a Senior Principal Pharmacovigilance Scientist.
Key Responsibilities
- Provide pharmacovigilance expertise and oversee operational activities for developmental and marketed products
- Conduct signal detection and safety monitoring activities, ensuring compliance and patient-focused safety data
- Represent the pharmacovigilance department in cross-functional teams and contribute to the development of safety protocols and reports
Required Qualifications
- Bachelor's degree required; advanced degree or pharmacovigilance qualification preferred (MD, Ph.D., PharmD)
- 6+ years of related experience, including safety signal detection and management
- Experience in medical assessment of individual cases and aggregate safety reports
- Strong database skills and understanding of MedDRA codes
- In-depth knowledge of clinical trial methodology and pharmacovigilance regulations
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