Head, Medical Safety

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 proteins 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 Head, Medical Safety to lead the global Medical Safety function and provide expert support to internal stakeholders including Clinical Operations, Medical and Regulatory Affairs on matters of patient/subject safety. Our goal is for the Head, Medical Safety to be responsible for the performance, line management and development of individuals and assume overall accountability for the expert output of the Medical Safety function. Successful execution will involve strong analytical and report writing skills to support the safety evaluation, benefit/ risk assessment, signal detection, aggregate safety report generation and responses to regulatory authority enquiries for Pharming Products.This is a hybrid role - must report to the Warren, NJ office 2 to 3 days per week.

Key Responsibilities

The Head, Medical Safety 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:

• Responsible for the identification, evaluation, management and escalation of safety risks for Pharming products.
• Manages the benefit-risk profile assessment of Pharming's products.
• Identifies, assesses, and monitors signal detection and signal management activities.
• Provides responses to enquiries from competent authorities (e.g., EMA, MHRA, and FDA) and partners.
• Ensures expertise in risk management planning and reporting.
• Provides medical input for aggregate reports, e.g., PSUR (PBRER) and DSUR.
• Leads CCDS/CCDI updates and collaborates with Global Regulatory Affairs team on labeling updates.
• Key member of Pharming's safety governance bodies inc. Safety Committee.
• Conducts medical reviews by making medical assessment on individual case reports including seriousness, causality, reportability etc. and contributes to medically informed follow-up queries.
• Provides information requested in audits and participates in inspections.
• Promotes the collection of (S)AEs associated with the use of Pharming's product(s).
• Oversees the safety set-up of all new studies including the preparation of study specific SAE processing documents and Safety Management Team (SMT) activities.
• Ensures the company complies with changing requirements through updating procedures and practices as appropriate
• Verifies compliance with current legal obligations and guidelines and other industry standards relating to PV by keeping up to date on changes in legislation and practices relating to PV.

Minimum Qualifications

• Doctor of Medicine (MD) degree from an accredited university.
• 6+ years of 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 operations especially from case processing and reporting perspective.
• In depth understanding of 21CFR, good pharmacovigilance practices (GVP) Modules and current drug safety/pharmacovigilance regulations.
• 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.
• Solid understanding of GCP/ICH guidelines.
• Experience in planning, allocating and managing multiple projects.
• Travels up to 10% 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 $210,000.00 TO $250,000.00 per year.

Compensation & Benefits

• Flexible hybrid work schedule to promote a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program.
• 401(k) plan with company match.
• Paid-Time Off Days.
• 16 Company Holidays per year (typically last week of December up until New Year's Day).

Other Benefits

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On Premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy - Continuing Learning & Development Program.

Additional Information

Pharming is an 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, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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.