Energy Jobline ZR
Senior PV Operations Specialist in Princeton
Energy Jobline ZR, Princeton, New Jersey, us, 08543
Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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 and 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.
Responsibilities
Perform intake, triage, data entry, and quality review of ICs and SCCs.
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 listing of 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.
Qualifications
Bachelor’s degree in life sciences, pharmacy, nursing, or related field.
3‑5+ years of experience in pharmacovigilance case processing.
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.
Compensation and Benefits 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 candidate’s qualifications, experience, and skills.
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.
We offer 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.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
#J-18808-Ljbffr
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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 and 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.
Responsibilities
Perform intake, triage, data entry, and quality review of ICs and SCCs.
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 listing of 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.
Qualifications
Bachelor’s degree in life sciences, pharmacy, nursing, or related field.
3‑5+ years of experience in pharmacovigilance case processing.
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.
Compensation and Benefits 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 candidate’s qualifications, experience, and skills.
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.
We offer 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.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
#J-18808-Ljbffr