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

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