Associate Medical Director, Medical Safety Evaluation/Medical Director, Medical Safety Evaluation

Role Summary

Associate Medical Director, Medical Safety Evaluation / Medical Director, Medical Safety Evaluation is responsible for supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of senior medical leadership to ensure safety through surveillance, signal detection, validation and assessment. The role involves interpreting pharmacovigilance regulations and supporting all patient safety activities.

Responsibilities

• Understands and applies the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Safety surveillance for pharmaceutical/biological/drug–device combined products; contributes to the authorship of key pharmacovigilance documents, including medical safety assessments, regulatory responses and risk management plans
• Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyzes and interprets aggregate safety data and communicates these analyses and interpretations to cross-functional teams
• Effectively writes, reviews and provides input on technical documents
• Leads the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
• Oversees safety surveillance and pharmacovigilance activities for products in clinical trials
• Leads and implements risk management strategy for assigned products

Qualifications

• MD / DO with 2+ years of residency with patient management experience
• 2–4 years of Pharmacovigilance experience in the pharmaceutical industry
• Effectively analyze and guide analysis of clinical data and epidemiological information required
• Effectively write technical documents with direction
• Ability to effectively present recommendation / opinions in a group environment
• Fluency, both written and oral, in English
• Self-starting and can work independently
• Work collaboratively and lead cross-functional teams