Senior Drug Safety Associate
Directed collection, data entry, coding, routing, follow-up, and timely reporting and submission of spontaneous, foreign and literature safety information in compliance with FDA regulations.
- Trained and mentored new drug safety associates, providing supervision and teaching key skills in Drug Safety.
- Handled initial and follow-up pharmacovigilance transactions from consumers, health care professionals, and attorneys, as necessary, in accordance with Forest policy and procedures.
- Assigned and completed expedited cases to ensure regulatory and client deadlines were met.
- Informed appropriate staff of delayed, missing or incomplete items; established follow-up procedures and completed all transactions in a timely manner.
- Minimized risk through active collaboration with Quality Standards and interfacing with management as needed.
- Expertise in safety system experience and case processing, interfacing with teams formed to assess the continuing safety profile for the compound or product.