Senior PV Operations Specialist
About The Position
SystImmune is a leading and well-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). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune 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 the company's success. 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 Systimmune’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 integrity, 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-related matters. This is not a remote role and requires in-office presence at least three days per week.
Requirements
- Bachelor’s degree in life sciences, pharmacy, nursing, or related 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.
Responsibilities
- Perform intake, triage, data entry, and quality review of ICSRs.
- Ensure timely 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 continuous improvement initiatives within 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 all regions/countries.
- Support the performance of root cause analysis of deviations relevant to PV systems.
- Prepare responses to audit findings that concern the PV department.
- Manage reconciliation activities with other departments within the company and vendors.
Benefits
- SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, 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, sick leave, plus 11 paid holidays and MORE.
- We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
- SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
