PV Operations Specialist - Rapidly Growing Oncology Biotech

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.

The PV Operations Specialist supports the Senior Director of Pharmacovigilance (PV) Operations in the oversight and execution of Systimmunes global pharmacovigilance function. The position carries full accountability for end-to-end safety case processing, including regulatory submissions, hands-on work within the safety database, and CAPA management and coordination

.
The incumbent is responsible for ensuring data integrity, optimal system performance, and compliance with global pharmacovigilance regulations and internal SOPs. The role requires close cross-functional collaboration with internal stakeholders and effective partnership with external vendors and service providers on pharmacovigilance-related activitie

s.
This is an on-site position, requiring in-office presence a minimum of three days per we

ek.
Key Responsibili

• ties
  Perform intake, triage, data entry, and quality review of I
• CSRs.Ensure timely regulatory submissions in accordance with global requirem
• ents.Maintain accuracy and completeness of safety data in the PV data
• base.Collaborate with cross-functional teams to support audits, inspections, and CAPA implementa
• tion.Follow SOPs, work instructions, and applicable regulations (e.g., FDA, EMA,
• ICH).Support continuous improvement initiatives within PV opera
• tionsFacilitate 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/coun
• triesSupport the performance of root cause analysis of deviations relevant to PV sy
• stemsPrepare responses to audit findings that concern the PV depar
• tmentManage reconciliation activities with other departments within the company and ve

ndorsQualifica

• tions
  Bachelors degree in life sciences, pharmacy, nursing, or related
• field3-5+ years of experience in pharmacovigilance case processing pre
• ferredFamiliarity with safety databases (e.g., ArisG, Argus) and regulatory reporting requir
• ementsStrong attention to detail, organizational skills, and ability to work indepen

dently
Compensation and Be

nefits:
The expected base salary range for this position is $85,000 - $115,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidates level qualifications, experience, and

skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of

the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the companys success. 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 applican