Remote Senior Director, Pharmacovigilance & Safety

The job is a remote position with a pioneering biotech company that focuses on developing innovative therapies for rare diseases. The Sr. Director/Safety Scientist will manage the safety profile of assigned products throughout clinical development and post-approval, ensuring compliance and managing relationships with CROs and regulatory authorities.

Responsibilities:

• 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.
• 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 protocols and informed consent forms (ICFs).
• Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically robust DSUR preparation, and alignment with corporate goals and KPIs.
• Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations.
• Prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as partners and regulatory authorities.
• Assist in the authoring of aggregate safety reports.

Skills:

• Bachelor's degree in a relevant discipline or equivalent is required; an advanced degree is preferred.
• Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety.
• Extensive experience with 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.
• Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements.
• Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and quality assurance.
• Experience managing clinical safety aspects of product defect investigations and assessments.
• Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or similar) and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project).
• Experience with regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews is highly preferred.
• Experience in drug safety audits and regulatory agency inspections.

Benefits:

• 401(k) with 100% employer match on the first 3% and 50% match on the next 2%.
• Employee stock purchase program.
• Tax commuter benefits.
• Referral program with a $2,500 award for successful referrals.
• Comprehensive health coverage with 100% of premiums covered for employees and dependents.
• Mental health support (6 therapy sessions and 6 coaching sessions).
• Hybrid work model with flexibility in where and how work is performed.
• Unlimited flexible time off.
• 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 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 educational opportunities.
• Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities.

The company focuses on the development and commercialization of precision medicines for various genetic diseases and cancers. It was founded in 2015 and is headquartered in Palo Alto, California, USA, with a workforce of 201-500 employees. Its website is http://company.com.