[Remote] Sr. Director, Drug Safety Operations

Note: The job is a remote job and is open to candidates in USA. reputed company is a biopharmaceutical company developing next-generation biologics across oncology, cardiovascular and metabolic diseases, immunology, and ophthalmology. The Sr. Director, Drug Safety Operations will lead global pharmacovigilance activities across the clinical development portfolio, overseeing safety surveillance, case processing, regulatory documentation, vendors, compliance, and cross-functional collaboration.

Responsibilities

• Support the Vice President, Drug Safety in executing Fortvita's global pharmacovigilance strategy
• Serve as the functional lead for day-to-day Drug Safety Pharmacovigilance operation activities
• Lead and mentor Drug Safety staff and cross-functional teams as guided by VP Safety
• Partner with the Vice President to build scalable pharmacovigilance infrastructure and processes
• Support Medical Safety Assessments, DSURs, PSURs/PBRERs, safety narratives, regulatory responses, investigator communications, and safety sections of IND, NDA, BLA, and MAA submissions
• Ensure compliance with FDA, EMA, ICH, GVP, and other global regulatory requirements
• Oversee pharmacovigilance vendors and CRO reputed company
• Establish vendor governance, KPIs, budgets, and service expectations
• Review vendor deliverables for quality and compliance
• Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Medical Writing, Clinical Science, Quality, Medical Affairs, and others as necessary
• Provide safety operations input into protocols, Investigator Brochures, informed consent documents, and Clinical Study Reports
• Support DMC/DSMB meetings and safety governance committees
• Maintain inspection-ready pharmacovigilance systems and documentation
• Support audits, inspections, and due diligence activities
• Contribute to SOP development and continuous process improvement
• Develop KPIs to monitor pharmacovigilance performance and vendor effectiveness
• Drive continuous improvement initiatives
• Perform other duties as assigned
• Lead or support other duties and ad-hoc projects as assigned by VP Safety
• Other duties as assigned

Skills

• • B.S, M.S. PharmD or equivalent degree required
• • Minimum 10 years of Drug Safety/Pharmacovigilance experience
• • Minimum 5 years of leadership experience
• • Experience supporting Phase I–III global clinical development programs
• • Strong oncology experience required
• • Knowledge of FDA, EMA, ICH E2 guidelines, GVP, and global pharmacovigilance regulations
• • Experience managing external pharmacovigilance vendors
• • Strong PV and scientific judgment
• • Strategic thinker with hands-on execution capability
• • Expertise in global pharmacovigilance and benefit-risk assessment
• • Excellent leadership and communication skills
• • Strong vendor governance and cross-functional collaboration
• • Commitment to quality, compliance, and continuous improvement
• Applicants must have legal authorization to work in the United States
• • Experience in a small or mid-sized biotechnology company
• • Experience interacting with global regulatory authorities
• • Experience supporting NDA, BLA, or MAA submissions

Benefits

• Remote (U.S.-based) work arrangement
• Preference is Hybrid – Palo Alto, CA

Company Overview

• reputed company is a biopharmaceutical company that develops biologic therapies for disease treatment. It was founded in undefined, and is headquartered in Palo Alto, California, USA, with a reputed company of 51-200 employees. Its website is https://www.fortvitabio.com.

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