The Senior Manager oversees pharmacovigilance activities, including the collection, evaluation, and reporting of adverse drug reactions to ensure regulatory compliance. They lead risk management strategies, signal detection, and the preparation of safety reports while collaborating with clinical and regulatory teams.
The Senior Manager will lead GCP audit strategies, conduct vendor and site audits, and manage quality systems including CAPAs and deviations. They will also drive inspection readiness activities and provide GCP expertise to ensure clinical trials comply with regulatory requirements.
Provides scientific and medical leadership for clinical research projects, including the development of core documents like protocols and target product profiles. Manages interactions with regulatory authorities, CROs, and key opinion leaders to ensure program objectives are met.
