Job Description

Associate Director, Drug Safety and Pharmacovigilance Operations

Join to apply for the Associate Director, Drug Safety and Pharmacovigilance Operations role at Rapport Therapeutics .

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, were driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And were doing this with extraordinary science and awesome people (affectionately called Rapptors).

Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.

High visibility role as DSPV Operations Lead, will play a critical, strategic and hands?on operational role in supporting PV across all clinical development programs.

Your Day?to?Day

Clinical Trial Support

• Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuring compliance with regulatory timelines and global regulations and guidelines.
• Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange.
• Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans.
• Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
• Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables.
• Collaborate cross?functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to.
• Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
• Lead DSPV Trial Master File document review, QC and provision to study specific TMFs.
• Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick?Off Meeting activities, requests for and attainment of information from cross?functional teams.
• Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.

Vendor Management

• Lead day?to?day operational oversight of pharmacovigilance service provider.
• Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals.
• Obtain close oversight of ICSR quality including performance of QC as needed.
• Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back?up testing, and other activities as required.
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance.

Quality and Compliance

• Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
• Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities.
• Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and PVAs.
• Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals.
• Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement.

Must?Haves

• Degree in Life Sciences, Pharmacy, Nursing or related field.
• 8+ years of experience in PV in Biotech, Pharma, or a CRO.
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance.
• Excellent decision?making and analytical skills.

What Makes Rapport Special

• Every role has meaning. Were determined to discover a better way for patients, and youll 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 youll 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 shouldnt 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 $170,000 to $185,000. 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 dont 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 Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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