Associate, Global Pharmacovigilance

Pharming Group N.V.•Warren Township, NJ

17h•$70,000 - $95,000•Hybrid

About The Position

This position is responsible for the case processing of all (S)AE reports for Pharming product(s) in the ARGUS safety database including conducting follow-up queries, requests, and reconciliation. In addition, responsible for coordinating and collaborating with GPV colleagues on assigned tasks. This is a hybrid position required to work from Pharming’s Warren, NJ office for 2-3 days per week. This is a salary non-exempt position which is eligible for overtime.

Requirements

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.
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

Nice To Haves

Alternatively, we would consider less experience if a candidate had an advanced degree in the life sciences, pharmacy, nursing or equivalent

Responsibilities

Review, triage, verify, book-in, and data enter reported (S)AEs associated with the use of Pharming’s product(s) both in development and authorized as per the compliance requirements of the competent authorities.
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.
Coordinate 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.
Other duties as assigned.
Occasional travel required.

Benefits

Flexible hybrid work schedule to promote a healthy work-life balance
Competitive compensation package including annual target bonus
Long-term incentive program
401(k) plan with company match
Paid Time Off (PTO)
13 Company Holidays per year
Excellent benefit plans including medical, dental, and vision
Flexible spending accounts
Company-provided life insurance, short-term disability, and long-term disability plans
Optional accident, hospital indemnity, critical illness, and pet insurance plans
Tuition reimbursement program
Health and wellness program
Choice of company provided mobile phone or cell phone stipend