Associate, Global Pharmacovigilance

Responsibilities

• Review, triage, verify, book-in, and data enter reported (S)AEs associated with the use of Pharming’s product(s).
• Perform case assessment including determining case validity and seriousness.
• Liaise with the Pharming QA department regarding product complaints.
• Determine and perform appropriate case follow-up activities including generation of follow-up requests via fax, phone, mail, or e-mail and product complaint notifications to consumers, HCPs, Specialty Pharmacies and/or vendors.
• Perform reconciliation of safety data across internal and external systems with Specialty Pharmacies, Contract Partners, and Data Management to ensure compliance with regulatory requirements.
• Cook up and schedule trainings for internal and external stakeholders as per GPV managers’ requests.
• Collaborate with the GPV team and ensure all assigned tasks (i.e., training) are completed within defined timelines.
• Other GPV tasks as assigned or requested by the GPV Operations Team and/or VP Pharmacovigilance.

Qualifications

• Bachelor of Science degree in the life sciences, pharmacy, nursing or equivalent.
• Minimum of 1 year of industry experience in pharmacovigilance and drug safety, which includes case processing, conducting follow-up activities, and coordination and collaboration with internal and external stakeholders.
• Alternatively, an advanced degree in the life sciences, pharmacy, nursing or equivalent, with less experience.
• Knowledge of Good pharmacovigilance practices and current drug safety regulations.
• Understanding of pharmacovigilance case processing including MedDRA coding.
• Safety database experience (ARGUS preferred).
• Knowledge of GCP/ICH guidelines.
• Commitment and alignment to Pharming’s mission, core values and behaviors.

Pay

Salary Range: From $70,000 to $95,000 per year.

Schedule

This is a hybrid position required to work from Pharming’s Warren, NJ office for 2-3 days per week.