Pharmacovigilance Manager

Job description

Pharmacovigilance Manager Position Summary: The Pharmacovigilance Manager is a managing professional with scientific, clinical, and therapeutic area expertise who is responsible for implementation of pharmacovigilance services for Med Communications PV clients. Essential Functions: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement(s): - Capability to perform activities of the PV Specialist and Sr. PV Specialist for case processing, literature processing, periodic report activities, and risk management activities. - Demonstrate proficiency in the use of the safety database and associated safety system(s). - Thoroughly and accurately document cases in the safety database, consistent with Client operational procedures, to ensure comprehensive case processing. - Knowledge of regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the appropriate entities. - Knowledge of regulatory and compliance guidelines to ensure periodic report submission t...