Role Overview

The Pharmacovigilance and Risk Management (PVRM) Senior Medical Director will be responsible for the medical safety aspects of clinical trials, including review and assessment of individual case safety reports, and providing medical safety subject matter expertise in the review and approval of documents.

What You Will Do

Lead safety strategy and key messaging in NDA/BLA/MAA submissions, provide PVRM Medical representation on product specific and/or clinical study team meetings and governance committees, and prepare and present safety data analysis to project teams and senior management.

Why It Might Be a Fit

This role requires a thorough knowledge of the pharma industry, especially clinical research and global regulatory requirements, and experience managing expedited and periodic safety reporting, signal generation, safety evaluation and risk management strategies.

Requirements

Medical Degree (MD) with 12 + years of relevant experience in biotech or pharmaceutical industry
Experience in Oncology and Neurology is preferred
Experience with NDA/BLA/MAA submission
Prior people management experience

Benefits

Merit-based salary increases
Short incentive plan participation
401(k) plan
Medical, dental, vision, life and disability insurances
Leaves provided in line with your work state
Flexible paid time off
11 paid holidays
Additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter

Originally posted on Himalayas

Senior Medical Director, PVRM at Sumitomo Pharma America