Manager - Global Pharmacovigilance

SummaryThis position provides safety evaluation of Pharming product(s), including case processing, signal detection and workups. Our goal for this position is to proactively manage potential safety issues, oversee the processing of (S)AE reporting, perform data retrieval and respond to regulatory agency safety enquiries. Successful execution will involve in depth knowledge of current drug safety regulations and a sufficient level of case management expertise. What you'd doCollecting and collating reported (S)AEs associated with the use of Pharming’s product(s) both in development and post-authorization.Checking reported information on completeness and consistency of data.Performing case assessment including determining seriousness, reportability etc.Entering all relevant data in the Pharmacovigilance database including editing narratives.Preparing follow-up queries and communicating with the reporters to obtain follow-up information for the (S)AEs received.Responsible for expedited submission of individual case safety reports to competent authorities, i.e., FDA, EMA, Ethics Committees, partners and other parties as applicable within timelines specified per applicable legal requirement (e.g., 7/15 day reporting timeline).Developing data output: database queries and data visualization in support of internal stakeholder requests (aggregate reports, signaling outputs, reconciliation, etc).Answering and/or supporting/contributing to the answering of questions from competent authorities.Performing reconciliation of safety information arising from clinical trials with data management.Alerting company personnel of any possible adverse changes to the risk-benefit profile of company products and providing relevant information as required to make an assessment.Maintaining a current awareness of legislation and practices relating to PV and ensuring the company complies with changing global requirements through updating procedures, practices and database configuration as appropriate.Designing and implementing procedures to ensure the smooth running of the Pharmacovigilance Department.Ensuring compliance of partner/distributors with local pharmacovigilance agreements by supporting routine and for cause GvP audits.Overseeing the database set-up of all new studies including the preparation of study specific SAE processing documents (e.g., Safety Reporting Plan).Assisting Business Development in all safety related issues required for the preparation of proposals/contracts for partners/distributors.Performing other related duties as assigned or requested by the PV Senior Manager and the VP, GPV.Providing out of office support for other PV staff, as required.Other duties as assigned.What you'd needBS Degree in relatable subjects i.e. life sciences, pharmacy or nursing; Masters or PharmD degree preferredAt least three years of industry experience in pharmacovigilance and drug safetyExtensive knowledge of pharmacovigilance especially case processing and drug safety evaluationExtensive knowledge of safety database (ARGUS strongly preferred)In depth understanding of good pharmacovigilance practices and current drug safety regulationsGood knowledge of GCP/ICH guidelines.Commitment and alignment to Pharming’s mission and valuesWho we are We’re built on a simple belief: people living with rare diseases deserve more. Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long-term commitment, and real partnership can help advance care. We put patients at the heart of our work. Their insights, along with those of caregivers, clinicians, scientists, and parters, shape our strategy, guide our decisions, and help turn science into meaningful progress. We keep it simple, act with urgency, and get it done – expanding access to approved therapies, advancing high-value pipeline programs, and building a leading global rare disease company. Our vision is simple: a world where people living with rare diseases don’t wait for progress or care. Together with the communities who inspire us, we’re opening new possibilities – proving that breakthroughs aren’t just discovered. They’re created together. Ready to make a difference? Join us. What it’s like to work here At Pharming, every role helps move rare disease therapies closer to the people who need them. We make it happen together, across teams, disciplines, and borders, because breakthroughs don’t happen in silos. Rare diseases are complex, and meaningful progress takes people who ask better questions, challenge each other, and turn insight into action. Here, you won’t work on the sidelines. Pharming is a place for builders, problem-solvers, and bold thinkers who move with urgency, take ownership, and stay focused on what matters most: improving the lives of people living with rare diseases. Advancing rare disease care isn’t the work of one team or one leader. It’s all of us, building what’s next together.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 $105,000 to $135,000 per year. Compensation & benefitsFlexible 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 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 in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to View email address on click.appcast.io. Unsolicited resumes from agencies should not be forwarded to Pharming.  Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established.  The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.