Associate Director Safety Science
Description
- Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
- Assist in follow-up of important ICSRs to ensure relevant information is sought.
- Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
- Participate in the development development of safety surveillance and risk management plans for drug development programs.
- Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report).
- Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed.
- Participate in the preparation and revision of company product labeling and RMP as appropriate.
- Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents.
- Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
- ICSR reviews in Argus safety database.
- Completed quarterly signal evaluation forms.
- Completed signal issue work-ups.
- Completed aggregate reports.
- Risk Management Plans.
- Slide decks for Safety Management Team/Product Safety Committee meetings.
Recommended Jobs
Heavy Equipment Mechanic
Job Description Job Description American Scissor lift is looking for an experienced service mechanic for our West Sacramento, CA branch. We are an independently owned rental company specializing …
Oakley - Specialized Consultant
Requisition I D : 893425 Store #: 00B222 Oakley Los Cerritos Position : Part-Time Total Rewards: Benefits/Incentive Information At Oakley, we believe everyone in the world can and …
Compliance Technical Project Manager - Consultant
Job Description Job Description Company Description About Sia Sia is a next-generation, global management consulting group. Founded in 1999, we were born digital. Today our strategy and m…
Full Time Urgent Care Physician Job CA
Urgent care opportunity near San Diego, California. Join an award-winning Medical Group. Job ID #73867 Job Details ~ BC/BE in Family or Emergency Medicine ~12-hour shifts ~ All physicians wor…
Manager, Robotics Software
About Us Saildrone is a defense company delivering maritime intelligence, surveillance, and reconnaissance products to military, homeland security, and commercial customers. Saildrone unmanned sur…
Empower Lives: Join Our Caring CNA Team Now!
Certified Nursing Aide Join our compassionate team in Huntington Beach as a Certified Nursing Assistant (CNA) and make a meaningful impact in the lives of residents. In this permanent role, you will…
E-Commerce Order Re-packer / Shipper
Job Description Job Description We are seeking an e-Commerce Order Re-packer and shipper to become an integral part of our team! You will help coordinate incoming and outgoing shipment activities…
Automotive Sales Executive
Automotive Sales Executive: Los Angeles, CA – C-4 Analytics C-4 Analytics is a fast-growing, private, full-service digital marketing company that excels at helping automotive dealerships increase …
Phlebotomist 2426
This is a contract job opportunity. Position: Phlebotomist 2426 Location: Laguna Hills CA and area Schedule: 1 st shift 6 Am to 6 PM Mon -Fri might be asked to cover a Saturday shift…