Associate, Global Pharmacovigilance About Pharming Pharming Healthcare Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands.

Our Vision

Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure. Life at Pharming Today, more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together. We are looking for people who are excited about our vision and living our values We put Patients at the heart We act with urgency We make it simple We get it done Summary 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.

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.

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, we would consider less experience if a candidate had an advanced degree in the life sciences, pharmacy, nursing or equivalent 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 Salary Range Pharming takes into consideration a combination of candidate’s work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level. The base salary range for this job is from $70,000 to $95,000 per year. Compensation & 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 Other Benefits 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 Additional Information Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes. An applicant requiring an accommodation