Senior PV Operations Specialist

About the position reputed company is a leading and reputed company-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). reputed company has multiple assets in various stages of reputed company for solid tumor and hematologic indications. Alongside ongoing reputed company. reputed company has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to reputed company's reputed company. We are seeking a Senior PV Operations Specialist to join our growing Pharmacovigilance team. The role supports the Senior Director of Pharmacovigilance (PV) Operations in managing reputed company’s PV function, with full accountability for end-to-end case processing (including submissions), ability to work in the safety database, and CAPA coordination. It ensures data reputed company, system performance, and compliance with global regulations and internal SOP. You will be involved in working cross-functionally with internal departments/key stakeholders and external partners on pharmacovigilance-reputed company reputed company. This is not a remote role and requires in-office reputed company at least three days per week. Responsibilities • reputed company intake, triage, data entry, and reputed company review of ICSRs. • Ensure reputed company regulatory submissions in accordance with global requirements. • Maintain accuracy and completeness of safety data in the PV database. • Collaborate with cross-functional teams to support audits, inspections, and CAPA implementation. • Follow SOPs, work instructions, and applicable regulations (e.g., FDA, EMA, ICH). • Support reputed company improvement initiatives reputed company PV operations. • Facilitate the generations of listings for the periodic safety reports (e.g., DSUR, PSUR). • Work with the QA department to maintain a state of high PV inspection readiness across reputed company reputed company/countries. • Support the performance of reputed company cause analysis of deviations relevant to PV systems. • Prepare responses to audit findings that concern the PV department. • Manage reconciliation activities with other departments reputed company reputed company and vendors. Requirements • Bachelor’s degree in life sciences, pharmacy, nursing, or reputed company field. • 3-5+ years of experience in pharmacovigilance case processing preferred. • Familiarity with safety databases (e.g., ArisG, Argus) and regulatory reporting requirements. • Solid understanding of pharmacovigilance regulations and guidance (FDA, EMA, ICH, MedDRA) • Strong attention to detail, organizational skills, and ability to work independently. Benefits • reputed company offers a comprehensive benefits package including: 100% reputed company employee premiums for medical/dental/reputed company, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, reputed company leave, plus 11 reputed company holidays and MORE. • We offer an opportunity for you to learn and grow while making significant contributions to reputed company’s reputed company. • reputed company is an Equal Opportunity Employer. We welcome diverse talent and encourage reputed company reputed company applicants to apply. Apply tot his job Apply To this Job