ZenGRC is hiring a Senior Director, Drug Safety and Pharmacovigilance

At Life360, where we ask ‘why not?’ and push boundaries to reengineer the future of biopharma, we are looking for a Senior Director, Drug Safety and Pharmacovigilance. You will oversee all aspects of your assigned product’s safety profile from clinical development to post-approval surveillance, establish safety strategy for regulatory submissions, and manage drug safety contract service organizations.

What You'll Do

• Oversee and understand all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners providing clinical and safety data.
• Facilitate the Safety Management Committee for designated product(s), identifying any emerging safety trends, defining the safety profile, and recommending safety actions based on cumulative data.
• In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including preparing CTD documents, engaging with regulatory authorities, and authoring responses to inquiries.
• Support the clinical development team in reviewing key documents, including protocols and ICFs.
• Manage 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 CRO functions meet corporate goals and KPIs.
• Assist in the medical review of adverse event reports and manage preparation and submission of expedited reporting in compliance with regulations, when necessary.
• Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management and external partners or regulatory authorities.
• Assist in authoring aggregate reports.

What We're Looking For

• Bachelor’s degree in a health care discipline or equivalent.
• At least ten years of drug safety and pharmacovigilance experience.
• At least 5 years of 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 required regulatory correspondence, and safety label updates.
• Experience in both clinical development and post-marketing safety.
• 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.
• Familiarity 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).

Nice to Have

• Advanced degree.
• Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews.

Technical Stack

• Argus, ArisG, VeevaSafety, Microsoft Office Suite

Team & Environment

You will collaborate with cross-functional clinical trial teams and external CROs.

Benefits & Compensation

• Market leading compensation: $255,000 - $340,000 USD.
• 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).
• Unlimited flexible paid time off.
• 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.
• Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching.

Work Mode

This position follows a hybrid work model - employees have autonomy in where and how they do their work. This role is open to candidates Remote - USA.

Life360 is an equal opportunity employer.