Associate Director

• 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

• 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

Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.

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

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.