Director, Pharmacovigilance Scientist

5 days ago

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Cogent Biosciences

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gastrointestinal stromal tumors (GIST) • Oncology • Systemic Mastocytosis • kinase inhibitors

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Description

• Cogent Biosciences develops solutions for genetically driven diseases. • Position: Director, Pharmacovigilance Scientist. • Oversee safety assessments and collaborate with cross-functional teams. • Impact drug development and regulatory adherence.

Requirements

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV • Minimum 8+ years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety, serving in a PV scientist role. • Experience in signal detection activities with demonstrated experience in analysis, and interpretation of medical and scientific data. • Knowledge of MedDRA terminology and its application. • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex information and safety data. • Experience in the preparation and authoring aggregate safety reports. • Knowledge of Pharmacovigilance regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). • Ability to work effectively in a collaborative small team environment. • Preferred Qualifications • Healthcare professional degree preferred (PharmD, RPh, RN, NP, PA) • Experience in early-stage oncology experience • Ability to work effectively in a collaborative small team environment • Must have excellent analytical and problem-solving ability • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities • Excellent communication skills and ability to influence multiple functions

Benefits

• Competitive pay • Performance-based bonus • Stock options • Insurance coverage (health, dental, life, and disability) • Competitive time-off • 401(k) plan • Commuter/parking benefits