Senior Director, Drug Safety and Pharmacovigilance Scientist at Rapport Therapeutics

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:

• Manager is 6+ years, and Sr. Manager has 8+ years’ experience.
• Bachelor's degree in Life/Health Sciences
• Strong familiarity with ICH E6 (R2) Good Clinical Practice requirements and GCP (R3) implementation.
• Knowledge of Quality Assurance principles, concepts, industry practices, and standards
• Experience with clinical study platforms including but not limited to – eTMF, EDC, eCOA, IRT, etc.
• Experience in participating in and overseeing GCP audits; experience including external CRO, clinical/regulatory and document auditing desirable.
• Experience in all phases of regulatory submissions and interactions; international experience preferred. Require minimal experience with mid/late phase clinical trial organizations.
• Experience in clinical trials with small molecules
• Strong communication and the ability to collaborate effectively across the organization.
• Demonstrated diplomacy, active listening, and a problem-solving mindset to foster a culture of continuous team-based improvement.
• Hybrid position with 1+ day per week in Boston office
• Ability to travel to clinical vendors/ clinical study site collaborators (up to 10%)

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.