Title:

Medical Reviewer, Associate Director, Safety and Risk Management (SRM)

Location:

Remote - EST / CST

Duration:

6 months

Summary of Key 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

Qualifications

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. Working knowledge of relevant

FDA, EU, ICH

guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred

Ability to work in fast-paced environment with rapidly approaching timelines is important

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We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

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