About Pharming
Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.
Our Culture
Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.
Overview
Pharming is seeking to hire a Director, Pharmacovigilance to lead the Global Case Processing Team and be responsible for safety evaluation of Pharming products. Our goal is to have the Director, Pharmacovigilance perform benefit/risk assessment of medicinal products, case processing, signal detection and workups as well as manage the processes for all (S)AE data and responses to safety requests from competent authorities worldwide. Successful execution will involve proactive management of potential safety issues and high knowledge of pharmacovigilance operation especially from case processing and reporting perspective. This role will have direct reports. In addition, this is a hybrid role - must be able to come into the US Office in Warren, NJ, 2 to 3 times per week.
Key Responsibilities
The Director, Pharmacovigilance will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.
Core functions include:
- Collaborating with the Vice President PV/EU QPPV to ensure the smooth running of the Global Pharmacovigilance Department.
- Managing the benefit-risk profile assessment of Pharming's products.
- Alerting leadership of any possible adverse changes to the risk-benefit profile of company products and providing relevant information as required to make an assessment.
- Conducting medical reviews by making medical assessment on individual case report including seriousness, causality, reportability etc. and preparing the appropriate follow-up queries.
- Leading team of Global Case processing PV Professionals.
- Identifying, assessing, and monitoring signal detection activities and signal management.
- Updating RMP package.
- Leading CCDS/CCDI updates and collaborating with Global Regulatory Affairs team on labeling updates.
- Act as PV contact person for any inquiries or issues within the US.
- Directing a process that collects and collates reported (S)AEs associated with the use of Pharming's product(s).
- Managing case processing in safety database.
- Providing responses to questions from Competent Authorities, e.g., EMA, MHRA, and FDA.
- Providing information requested in audits and participating in inspections.
- Ensuring the company complies with changing requirements through updating procedures and practices as appropriate by keeping up to date on changes in legislation and practices relating to PV.
- Ensuring compliance with current legal obligations and guidelines and other industry standards relating to PV.
- Providing data on aggregate reports, e.g., PSUR (PBRER) and DSUR, from medical perspective.
- Overseeing the set-up of all new studies including the preparation of study specific SAE processing documents and Safety Management Team (SMT).
- Serve as a backup for Director of PV (MD) in the EU.
- Performing other related duties as assigned or requested by the Vice President PV/EU QPPV.
Minimum Qualifications
- Doctor of Medicine (MD) degree preferred.
- Minimum 6 years of solid and proven industry experience in pharmacovigilance and drug safety, both for Medicinal Products under development and marketed Medicinal Products.
- Proven experience in leading a global team.
Preferred Qualifications
- Highly knowledgeable in pharmacovigilance operation especially from case processing and reporting perspective.
- In depth understanding of good pharmacovigilance practices (GVP) Modules and current drug safety/pharmacovigilance regulations.
- Strong understanding of GCP/ICH guidelines.
- Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, and build consensus across departments internally and suppliers externally.
- Experience in planning, allocating and managing multiple projects.
- Computer proficient.
Travel Requirements
- Travels up to 15% based on business need.
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 $220,000.00 to $250,000 per year.
Additional Information
Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.
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 HR-US@pharming.com.
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.
Please note that we review every submission, and we will keep submissions on file for six months.
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