Associate Director, PV Scientist
About The Position
Reporting to the Head of Pharmacovigilance, the Associate Medical Director, PV Scientist supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data at Praxis. This role contributes to high-quality safety surveillance, signal detection, benefit-risk evaluation, and regulatory compliance across clinical development programs. As Praxis advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor oversight, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The Associate Medical Director, PV Scientist enables the PV Lead to focus on clinical safety strategy, regulatory submission activities, and labeling development by providing both strategic and operational support across safety activities.
Requirements
- Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.
- Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.
- Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.
- Experience in individual case safety reporting (clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, and PV SOP development.
- Familiarity with MedDRA and WHO-Drug coding.
- Excellent written and verbal communication skills.
Nice To Haves
- At least 1 year of clinical trial experience highly desirable.
- Experience with regulatory filings (INDs, NDAs, MAAs).
- Experience implementing safety databases and signal detection tools preferred.
Responsibilities
- Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones. Proactively identify and resolve operational gaps before they become compliance risks.
- Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. Ensure quality, timeliness, and regulatory compliance at all times.
- Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations. Lead or support implementation of new safety tools (e.g., signal detection platforms, monitoring systems) to strengthen proactive surveillance.
- Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings. Author signal assessments, benefit-risk evaluations, and health hazard evaluations with scientific rigor and clarity.
- Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensure TMF documentation is complete, accurate, and inspection ready. Maintain compliance with global safety reporting requirements.
- Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality to ensure aligned safety processes, including call center setup, partner safety data exchange, and commercialization readiness activities.
- Ensure safety data exchange complies with partner agreements. Author searches for strategies for regulatory queries and internal requests. Maintain rigorous documentation standards to support inspections and audits.
Benefits
- At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
- To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
