Sr. Director, Drug Safety Operations

Fortvita Biologics; United States; Hybrid; USD 240,000 - 300,000; Full time

Job summary

Fortvita Biologics is seeking a Sr. Director of Drug Safety Operations to lead global pharmacovigilance across our growing portfolio.

Reporting to the VP of Drug Safety, this role provides strategic and operational leadership for product safety surveillance across the lifecycle. The position requires extensive experience in drug safety, oncology, vendor management, and regulatory compliance with FDA/EMA guidelines.

Qualifications

• B.S, M.S. PharmD or equivalent degree.
• Minimum 10 years of Drug Safety/Pharmacovigilance experience.
• Minimum 5 years of leadership experience.
• Strong oncology experience required.
• Knowledge of FDA, EMA, ICH E2 guidelines, GVP, and global pharmacovigilance regulations.
• Experience managing external pharmacovigilance vendors.

Responsibilities

• Lead and execute Fortvita's global pharmacovigilance strategy.
• Oversee day-to-day pharmacovigilance operations and safety system management.
• Coordinate with cross-functional teams for safety signal management and regulatory submissions.
• Maintain inspection-ready pharmacovigilance documentation and vendor governance.
• Drive KPIs, process improvements, and safety governance across the portfolio.

Skills

Leadership

PV expertise

Strategic thinking

Cross-functional collaboration

Vendor management

Education

B.S, M.S. PharmD or equivalent

Job description

Remote (U.S.-based) - CA, CO, CT, DC, FL, IL, IN, MA, MD, MN, MT, NH, NJ, NY, NC, PA, RI, TX, UT, VA, WA

Preference is Hybrid – Palo Alto, CA

Travel up to 20% required

ABOUT THE COMPANY

Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

POSITION SUMMARY

Fortvita is seeking an experienced and collaborative Sr. Director, Drug Safety Operations, to lead global pharmacovigilance activities across our growing clinical development portfolio. Reporting to the Vice President, Drug Safety, this individual will provide strategic and operational leadership for product safety surveillance throughout the product lifecycle while partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biometrics, Medical Affairs, Quality, IT and other relevant functions.

The Sr. Director will serve as the functional leader for day-to-day pharmacovigilance operations, ensuring the timely identification, end to end processing of ICSRs, evaluation, communication, and management of product safety risks across global clinical programs. This role will oversee or contribute to operational aspects of case management, safety systems, aggregate safety reporting, vendor management, safety quality, and regulatory compliance while helping build scalable pharmacovigilance capabilities to support Fortvita's expanding pipeline.

As a key member of the Drug Safety leadership team, the Senior Director will work closely with the Vice President, Drug Safety to execute the department's strategic priorities, strengthen operational excellence, and maintain inspection-ready pharmacovigilance processes supporting global clinical development and future regulatory submissions. The incumbent will also create and maintain safety documents (e.g. PVAs and SMPs) and collaborate with business partner interactions

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Drug Safety Leadership

• 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.

Regulatory & Medical Safety Documentation

• 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 partners.
• Establish vendor governance, KPIs, budgets, and service expectations.
• Review vendor deliverables for quality and compliance.

Cross-Functional Collaboration

• 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.

Inspection Readiness & Compliance

• Maintain inspection-ready pharmacovigilance systems and documentation.
• Support audits, inspections, and due diligence activities.
• Contribute to SOP development and continuous process improvement.

Operational Excellence

• Develop KPIs to monitor pharmacovigilance performance and vendor effectiveness.
• Perform other duties as assigned.
• Lead or support other duties and ad-hoc projects as assigned by VP Safety

Other duties as assigned

REQUIRED QUALIFICATIONS

• B.S, M.S. PharmD or equivalent degree required.
• Minimum 10 years of Drug Safety/Pharmacovigilance experience.
• Minimum 5 years of leadership experience.
• Strong oncology experience required.
• Knowledge of FDA, EMA, ICH E2 guidelines, GVP, and global pharmacovigilance regulations.
• Experience managing external pharmacovigilance vendors.

PREFERRED QUALIFICATIONS

• Experience in a small or mid-sized biotechnology company.
• Experience interacting with global regulatory authorities.
• Experience supporting NDA, BLA, or MAA submissions.

COMPETENCIES/CORE SKILLS

• 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.

COMPENSATION

• The base salary range for this position is $240,000–$300,000. Actual starting pay is determined based on the candidate's years of relevant experience, educational background, and demonstrated skills.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at [e-mail]. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Employment may be contingent upon successful completion of a background check and any other requirements permitted by law.