Job Order ID : 43017
Location : South San Francisco, CA
Duration : 8+ Months
Job Title : Scientist I
Job Description:
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
- Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet
- Conduct/support signal detection and evaluation according to SOPs and guidelines
- Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP
- Contribute to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
- Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
- The Safety Scientist should develop a clear understanding of the safety issues and a thorough knowledge of the from the drug mode of action, to enable support the SSL
- The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP) and develop an understanding of the safety profile of the assigned product
Skills:
- Strong knowledge of international drug regulation including GCP, GVP and GMP
- Prior industry experience in drug safety, clinical development or medical affairs is desirable
- MD candidates - clinical practice experience (at least 3 years preferred, may include residency)
- Good knowledge of pharmacovigilance practices
- Good knowledge of US and EU pharmacovigilance regulatory requirements
Education:
- MS or MD, PhD or PharmD Preferred, or equivalent qualification.
