Senior Director, Drug Safety and Pharmacovigilance Scientist

Your impact:

High visibility role in support of all clinical development programs to ensure potential risks are identified and managed, as well as leading aggregate safety reporting for assigned programs

Your day-to-day:  

You will provide scientific, clinical, and pharmacovigilance expertise along with strategic and operational support for key deliverables and activities in clinical development including:

Product Oversight

• Overseeing aggregate reports production, clinical trial and any post marketing activities, signal management, literature review, and ad hoc regulatory responses for assigned product group
• Lead product safety surveillance activities for assigned product(s) during all phases of the product lifecycle (includes both investigational and marketed products).
• Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor.

Clinical Trial Support

• Participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB/DMC activities, coding review as well as SAE reconciliation activities.
• Review study protocols, statistical analysis plans and other clinical study-related documents
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities
• Manage updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information.

Aggregate Reports, Risk Management Plans, and REMS Activities

• Demonstrate effective leadership skills with cross functional partners to ensure that safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines.
• Lead PSUR/PADER/DSUR strategy, preparation and adherence to timelines with key stakeholders and vendors.
• Support RMP updates as appropriate for the assigned product(s).
• Contribute to the development of Risk Evaluation and Mitigation Strategies (REMS) or REMS amendments.
• Supports preparation of REMS assessment reports by contributing to the safety-relevant sections.

Signal Detection and Management

• Implement signal detection strategy approved by the Safety Surveillance Team (SST) and Safety Review Committee (SRC).
• Review adverse event data, literature, and other safety-relevant data for signal detection.
• Prepare review of potential safety signals for Head of DSPV.
• Responsible for signaling review and the coordination and documentation of all signal review activities with the product safety physician and product complaint staff. This includes performing signal investigations and drafting signal investigation reports.
• Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the product safety physician, biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.
• Support in preparing SST/SRC slides and documenting meeting minutes.

Procedures and Compliance

• Ensure PV activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management plans are adequate.
• 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.
• Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.
• Facilitate inspection readiness activities, if applicable.
  

Must-Haves:

• RN, PharmD, NP, MD, MS, DVM
• Relevant life science background and a minimum of 12 years of experience in drug safety serving in a PV Scientist or similar role
• Demonstrated experience in analysis and interpretation of medical and scientific data, with excellent verbal and written skills. 
• Experience in safety surveillance systems, aggregate reports, case management and global regulatory processes, ensuring quality and compliance with regulations.
• Demonstrated ability to provide strategic input in the preparation of responses to Regulatory Authority(ies), authoring of safety topic reports, and aggregate report preparation.
• Demonstrated ability to work effectively either independently or collaboratively in a cross-functional team environment, as well as with external colleagues.
• Strong organizational, project management and leadership skills: leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
• Oversees and mentors less experienced PV Scientist staff.
• Applies clinical judgment to interpret case information.
• 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 that 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 $270,000 to $290,000. 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.