Sr. Medical Director, Pharmacovigilance

MD or equivalent with 3-5 years of relevant clinical experience

Minimum 10 years’ industry experience, within Drug safety/Pharmacovigilance with investigational and/or marketed products

Preferred: experience in NDA/IND submissions in neuroscience, psychiatry or neurodegenerative therapeutic area

Proven experience in safety data analysis, signal management, and benefit-risk evaluation

Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)

Proven experience with authoring or contributing to clinical study and regulatory submission documents

The Senior Medical Director, Pharmacovigilance will lead the medical safety evaluation and benefit-risk assessment for products throughout their lifecycle with focus on patient well-being and compliance and applicable regulatory requirements.

This person will lead cross-functional safety management team (SMT) and collaborate with other members Clinical Development and Medical Affairs (CDMA), contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety and benefit-risk assessment is performed adequately for assigned products.

Reporting to the Vice President, Pharmacovigilance, the Senior Medical Director will oversee cross-functional teams and may have direct reports

Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products.

Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle.

Review safety data from various sources (e.g.