Associate Director, Medical Reviewer

Job Description

Duties and 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.

Education and Experience:

• 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.

Knowledge, Skills and Abilities:

• 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.