Senior Director - Pharmacovigilance Scientist
Our Biotech client is specialized in hematologic and musculoskeletal disorders. They are expanding their PV teams looking to bring on a Senior Director to serve as a data analytical expert for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively. They must possess knowledge and skills to ensure that safety data analysis and reports are of high quality and in adherence to requirements and regulatory timelines. Accountability in leading and managing projects as well as ability to analyze, interpret, and effectively communicate data is a key success factor for this role.
What You'll Do
Serve as the analytical safety lead for the assigned program(s)/product(s).
Responsible for signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
Review data outputs and literature, interpret and communicate findings.
Analyze data for aggregate safety reports (e.g., DSURs, PADERs, PBRERs), and ad-hoc regulatory requests.
Support Risk Management Plan (RMP) related activities.
Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses to health authorities.
Qualifications
Advanced degree (PharmD, MD, PhD, MPH, NP, MS).
Demonstrated experience in analysis and interpretation of medical and scientific data.
In-depth understanding of research methods and procedures; strong background in epidemiological theory, methods, or health informatics is a plus.
Experience in signaling activities, aggregate reports authoring, and responding to regulatory requests.
Strong knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations.
Familiarity with case processing, expedited reporting rules, and safety database concepts.
Strong knowledge/proficiency with Microsoft Office Suite and Argus Safety systems
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