Senior Director, Drug Safety and Pharmacovigilance

Job Description:

• Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
• Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
• In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
• Support the clinical development team in the review of key documents, including protocol and ICFs
• Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators
• Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
• Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
• Assist in the authoring of aggregate reports

Requirements:

• Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred
• Requires at least ten years of drug safety and pharmacovigilance experience with at least 5 years experience in Clinical Development Safety
• Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates
• Experience in both clinical development and post-marketing safety
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews is highly preferred
• Experience in drug safety audits and agency inspections
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
• Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
• Experience in managing all clinical safety aspects of product quality defect investigations and assessments
• Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)

Benefits:

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office

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