Associate Director, Pharmacovigilance/ Product Safety

Responsibilities

• Evaluate safety data and risk assessments for products
• Compile analyses of adverse events for health authorities
• Provide medical input for Risk Management Plans
• Conduct periodic benefit-risk assessments internally
• Investigate emerging safety data from various sources
• Author and review drug-safety regulatory reports and clinical documents
• Collaborate with drug safety vendors for medical review

Qualifications

• Master's degree in life sciences, RN, PharmD or MD required
• 3-5 years in safety officer or equivalent pharmacovigiveance leadership role
• Device experience preferred
• Expert knowledge of pharmacovigilance regulations
• Proficient in industry standard pharmacovigilance databases and MedDRA
• Strong leadership and communication skills
• Attention to detail and organizational skills

Benefits

• Comprehensive medical, dental, and vision coverage
• Generous paid time off and flexible work schedules
• 401(k) plan with competitive matching and equity awards
• Access to learning and development programs
• Employee resource groups and volunteer opportunities