Associate Director

TalentBurst•Cambridge, MA

2d•Hybrid

About The Position

This role involves performing daily medical review and causality assessment of Individual Case Safety Reports (ICSRs) to ensure accuracy, consistency, and timeliness, contributing to the continuous signal detection and management process. The Associate Director will collaborate with pharmacovigilance colleagues to harmonize the identification, evaluation, and communication of safety issues. This position also involves identifying topics for escalation and working with safety product leads to investigate potential safety signals. Collaboration with SRM Quality and Case Management teams to address case review issues and inconsistencies is expected, under the leadership of the Head of Medical Review. The role also includes participation in process improvements for the Medical Review team and maintaining close communication with case processing and medical case review vendors.

Requirements

MD degree with a minimum of 1 year of medical practice is required
Must have a minimum of 2 years of pharmaceutical industry experience as a medical reviewer
Sound clinical acumen and a wide range of therapeutic area knowledge
Ability to synthesize and analyze safety data from various sources
Proficiency in problem-solving within a highly complex environment
Excellent written and oral communications skills
Expertise in international regulations governing drug safety
Ability to work in fast-paced environment with rapidly approaching timelines is important

Nice To Haves

Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred

Responsibilities

Perform daily medical review and causality assessment of ICSRs in accurate, consistent, and timely manner to contribute to continuous signal detection and management process
Collaborate with other pharmacovigilance colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues
Identify topics for escalation and collaborate with safety product leads to investigate potential safety signals
Collaborate with SRM Quality and Case Management teams to identify case review issues and inconsistency and work on addressing these issues under the leadership of Head of Medical Review
Participate in process improvements for the Medical Review team
Maintain close communication with the case processing and medical case review vendors