Your impact:

Key supporting role for all clinical development programs to ensure ongoing safety analysis, prompt management of potential safety signals, and establishment of in-house aggregate safety reporting system for assigned programs.

Your day-to-day:  

Product Oversight

• Lead aggregate reports production, DSPV Safety Science clinical study team (CST) representation and any post marketing activities, and literature review.
• Supports rapid responses to ad-hoc safety data and analysis requests from any source
• Facilitate updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information following endorsement by safety governance teams.
• Key analytic and safety support lead in close collaboration with the Head of DSPV, Head of Safety Science, DSPV Safety Physician, and Medical Science Lead.

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, IB, ICF, CSR, statistical analysis plans and other clinical study-related documents.
• Review standard design of tables, figures, and listings for safety data from clinical studies.
• Participate in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities.

Aggregate Reports, Risk Management Plans, and REMS Activities

• Lead development and implementation of an in-house aggregate report strategy (DSUR/PSUR/PADER), preparation and adherence to timelines with key stakeholders and vendors.
• Lead development and implementation of an in-house literature surveillance process.
• 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.
• 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

• Lead safety signal management documentation including preparation of the Safety Topic Report and maintenance of the signal tracker, for assigned products.
• Review adverse event data, product complaints, literature, and other safety-relevant data for signal detection.
• 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.

Procedures and Compliance

• Ensure PV activities remain compliant with evolving regulations (including new US FDA requirements to track and report Anticipated SAEs and increases in SARs), 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 8+ years of experience in drug safety serving in a PV Scientist or similar role
  • Level commensurate with experience
• 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 $185,000 to $205,000 for Associate Director level and $215,000-235,000 for Director level. 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:

This role is onsite in our Boston office. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.