What are the responsibilities and job description for the Pharmacovigilance Specialist - Adverse Event Case Processing position at JMD Technologies Inc.?
Title: Pharmacovigilance Specialist – Adverse Event Case Processing
Location: Greater Waltham Area, MA (Hybrid 3 days onsite)
Employment Type: Contract
Status: Accepting Candidates
About the role
Support clinical and post-market pharmacovigilance activities with a primary focus on adverse event case processing, safety operations, and clinical project support. Work cross-functionally with clinical, regulatory, quality, CRO, and other partners.
Key Responsibilities
- Process adverse event reports for marketed and investigational products through case closure.
- Apply clinical judgment when coding adverse events, medical history, and medications.
- Obtain follow-up information and perform SAE reconciliation for case completeness and closure.
- Coordinate with CROs, investigator sites, and internal cross-functional teams.
- Support safety surveillance, events of special interest, and aggregate data review.
- Support pharmacovigilance audits, inspections, SOPs, and safety reporting activities.
Qualifications
- 3 years of Drug Safety or Clinical Safety experience with hands-on AE case processing.
- Hands-on experience with Argus, ArisG, or Clintrace.
- Clinical/scientific degree such as PharmD, RPh, RN, or BSN.
- Strong clinical and pharmacology knowledge with sound clinical judgment.
- Knowledge of FDA, ICH pharmacovigilance requirements, and GCP.
- Oncology case-processing experience strongly preferred.
Compensation (MA Pay Transparency):
- Estimated hourly range: $50/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.
Salary : $50