Vice President, Head of Drug Safety and Pharmacovigilance chez Rapport Therapeutics

Your impact:

High visibility role in support of the DSPV infrastructure, safety governance, and management of DSPV staff, with oversight of risk management for all clinical development programs

Your day-to-day:  

Oversight of all DSPV activities including SOPs, vendor management, pharmacovigilance agreements, safety governance, risk management, DSPV input to clinical development and clinical study teams, and safety input to regulatory strategy and documentation:

DSPV Infrastructure

• Maintaining DSPV SOPs and templates in compliance with GVP guidance
• Ensuring that DSPV activities remain compliant with evolving regulations
• Selecting and overseeing vendors, with appropriate KPI adherence
• Ensuring Rapport DSPV is future-proofed, particularly the ability to scale process and staff as demands increase and the support of a commercial product approaches
• Establishing and maintaining pharmacovigilance agreements with partners
• Ensure clinical study teams (CSTs) are fully staffed by DSPV (operations and safety science) so that appropriate input to clinical study protocols, safety data case report forms, and safety monitoring plans is provided
• Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and compliance with global regulations
• Contributing to initiatives for process improvement and cross-product process consistency
• Facilitating inspection readiness activities across DSPV and with cross-functional partners

Safety Governance

• Overseeing risk management activities for all programs
• Establishing program-specific safety surveillance teams (SSTs) and appropriate escalations to the safety review committee (SRC)
• Leading safety surveillance activities and signal management for all programs during all phases of the product lifecycle (including both investigational and marketed products)
• Ensuring that aligned and accurate safety messaging is incorporated into integrated safety summaries, regulatory documents, aggregate safety reports, and ad hoc regulatory responses
• Managing updates to reference safety information, including Investigator Brochures and Company Core Safety Information, and coordinating ad hoc safety queries or health hazard evaluations as needed
• Providing escalation point for the review of potential safety signals across all programs

Management of DSPV Function

• Demonstrating effective leadership skills with cross functional partners to ensure that DSPV input is sought and provided in a timely manner across all programs
• Ensuring that DSPV is “right sized” with high-quality, skilled and experienced staff to deliver world-class DSPV activities
• Preparing an appropriate DSPV annual budget

Must-Haves:

• RN, PharmD, NP, MD, MS/PhD, DVM or equivalent
• Relevant life science background and a minimum of 15+ years of experience in drug safety serving in a PV Scientist or similar role
• Demonstrated leadership of a DSPV function or large DSPV sub-function 
• Demonstrated leadership skills, with a great reputation for effective cross-functional interactions
• Demonstrated excellence in managing and mentoring DSPV staff
• Demonstrated ability to provide strategic safety input to regulatory strategy and clinical development planning
• Strong organizational, project management and leadership skills
• Solid knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations, including familiarity with case processing, expedited reporting rules, and safety database concepts
• Experience working with all levels of management and consulting with key business stakeholders with an ability to influence for greater outcomes
• Strong team player who has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Possesses strong written and verbal communication skills

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $300,000 to $330,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Tuesday and Wednesday. In January 2026, this will shift to three days a week to create more opportunities for innovation, collaboration, and connection.