Senior PV Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the U.S. facing leader in pharmacovigilance, ensuring prompt follow-up on safety actions across global teams and various time zones.

• Oversee the entire process of pharmacovigilance service providers, which includes governance meetings, KPI tracking, TMF documentation, and ongoing process enhancement.

• Play a key role in the creation and advancement of pharmacovigilance SOPs, safety management plans, and database transitions.

• Assist in signal detection efforts, conduct literature reviews, prepare aggregate reports, and participate in safety governance meetings.

• Write signal assessments, benefit-risk analyses, and health hazard evaluations with scientific precision and clarity.

• Prepare and/or perform quality control on safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB documentation.

• Work collaboratively with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality teams to ensure cohesive safety processes.

• Ensure that safety data exchanges adhere to partner agreements.

⛳️ Requirements

• Must be a Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.

• A minimum of 3-5 years of experience in pharmacovigilance within the pharmaceutical or biotechnology sector.

• A minimum of 1 year of clinical trial experience is strongly preferred.

• Familiarity with regulatory submissions (INDs, NDAs, MAAs) is required.

• Comprehensive understanding of FDA, EMA, ICH, and GVP pharmacovigilance regulations.

• Experience in individual case safety reporting (both clinical and post-marketing), aggregate reporting, signal detection, risk management planning, regulatory inspections, and the development of pharmacovigilance SOPs.

• Previous experience in implementing safety databases and signal detection tools is preferred.

• Knowledge of MedDRA and WHO-Drug coding is beneficial.

• Outstanding written and verbal communication skills are essential.

🏝️ Benefits

• Health insurance

• 401(k) retirement plans

• Paid time off

• Flexible work arrangements

• Professional development opportunities