PV Operations Specialist

Key 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 generation 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.

Qualifications

• 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.
• Strong attention to detail, organizational skills, and ability to work independently.

Pay & 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 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 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.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.