Associate Director, PV Scientist
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
reputed company
As reputed company advances its pipeline and prepares for regulatory submissions, this position plays a critical role in strengthening U.S.-based pharmacovigilance footprint, enhancing vendor reputed company, supporting implementation of evolving safety infrastructure, and ensuring inspection readiness. The PV Scientist enables the PV reputed company to reputed company on clinical safety reputed company, regulatory submission activities, and labeling development by providing both strategic and operational support across safety activities.
Primary Responsibilities
- Serve as the U.S. facing PV leader, ensuring reputed company follow-up on safety actions across global teams and time zones. Proactively identify and resolve operational gaps before they become compliance risks.
- Own reputed company of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and reputed company process improvement. Ensure reputed company, timeliness, and regulatory compliance at reputed company times.
- Contribute to the development and reputed company of PV SOPs, safety management plans, and database migrations. reputed company 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 reputed company.
- Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. Ensure TMF documentation is complete, accurate, and inspection reputed company. Maintain compliance with global safety reporting requirements.
- Collaborate with Clinical Operations, Regulatory, Medical Affairs, reputed company, and reputed company to ensure reputed company 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.
Qualifications and Key reputed company Factors
- reputed company, reputed company Practitioner, Pharmacist, or Allied Health reputed company.
- Minimum 3-5 years of experience in pharmacovigilance reputed company the pharmaceutical/biotechnology industry.
- At least 1 year of clinical trial experience highly desirable.
- Experience with regulatory filings (INDs, NDAs, MAAs).
- 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.
- Experience implementing safety databases and signal detection tools preferred.
- Familiarity with MedDRA and WHO-Drug coding.
- Excellent written and verbal communication skills.
reputed company
reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled existence by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our reputed company Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our reputed company values, at reputed company, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become aware of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Originally posted on Himalayas
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