Sr. Director/Safety Scientist, Pharmacovigilance Operations
We are looking for a Sr. Director/Safety Scientist to oversee all aspects of a product's safety profile from clinical development to post-approval safety surveillance. The ideal candidate will have a strong background in drug safety and pharmacovigilance, including experience with regulatory submissions, safety signal evaluation, and data analysis.
Requirements
ā¢ Bachelor's degree in a healthcare discipline or equivalent
ā¢ Minimum of ten years of drug safety and pharmacovigilance experience
ā¢ Experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
ā¢ Experience in both clinical development and post-marketing safety
ā¢ Regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews
ā¢ Experience in drug safety audits and regulatory agency inspections
ā¢ Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Benefits
ā¢ Market-leading compensation
ā¢ 401(k) with 100% employer match on the first 3% and 50% match on the next 2%
ā¢ Employee stock purchase program
ā¢ Pre-tax commuter benefits
ā¢ Referral program with a $2,500 award for hired referrals
ā¢ Comprehensive health coverage with 100% of premiums covered for employees and dependents
ā¢ Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
ā¢ Hybrid work model with flexibility in where and how work is performed
ā¢ Unlimited flexible paid time off
ā¢ Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents
ā¢ Flexible spending accounts and company-provided group term life and disability insurance
ā¢ Subsidized lunches via Forkable on in-office days
ā¢ Opportunities for growth from discovery through late-stage development and FDA pipelines
ā¢ Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching
ā¢ Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities
Apply Now
Apply Now
Requirements
ā¢ Bachelor's degree in a healthcare discipline or equivalent
ā¢ Minimum of ten years of drug safety and pharmacovigilance experience
ā¢ Experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
ā¢ Experience in both clinical development and post-marketing safety
ā¢ Regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews
ā¢ Experience in drug safety audits and regulatory agency inspections
ā¢ Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Benefits
ā¢ Market-leading compensation
ā¢ 401(k) with 100% employer match on the first 3% and 50% match on the next 2%
ā¢ Employee stock purchase program
ā¢ Pre-tax commuter benefits
ā¢ Referral program with a $2,500 award for hired referrals
ā¢ Comprehensive health coverage with 100% of premiums covered for employees and dependents
ā¢ Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
ā¢ Hybrid work model with flexibility in where and how work is performed
ā¢ Unlimited flexible paid time off
ā¢ Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents
ā¢ Flexible spending accounts and company-provided group term life and disability insurance
ā¢ Subsidized lunches via Forkable on in-office days
ā¢ Opportunities for growth from discovery through late-stage development and FDA pipelines
ā¢ Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching
ā¢ Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities
Apply Now
Apply Now