Director pharmacovigilance

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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.

The role:
We are looking for a highly experienced Pharmacovigilance Director to lead our Pharmacovigilance team.
As the Pharmacovigilance Director, you will be responsible for the safety evaluation of Pharming's product portfolio.
This includes conducting benefit/risk assessments of medicinal products, overseeing case processing, signal detection and workups, and proactively managing potential safety issues

overseeing the processing of (S)AE reporting, management of the processes for all (S)AE data and responses to safety requests from Competent Authorities worldwide.

Areas of responsibility:

• Supports the Vice President PV/EU QPPV to ensure the smooth running of the Global Pharmacovigilance Department
• Responsible for benefit-risk profile assessment of Pharming's products
• Alerts company personnel of any possible adverse changes to the risk-benefit profile of company products and to provide relevant information as required to make an assessment.
• Responsible for signal detection activities and signal management.
• Responsible for RMP update
• Takes the lead of CCDS/CCDI update, and collaborates with Global Regulatory Affairs team in discussion, preparation, and compilation, quality checking of labeling update.
• Acts as local PV contact person wherever needed
• Collects and collates reported (S)AEs associated with the use of Pharming's product(s) both in development and authorized
• Oversees the case processing in safety database
• Conduct medical review by making medical assessment on individual case report including seriousness, causality, reportability etc., prepares the follow-up queries as appropriate
• Answers and/or supports/contributes to the response of questions from Competent Authorities, e.g., EMA, MHRA, and FDA
• Participates in audits or inspections whenever needed
• Maintains a current awareness of legislation and practices relating to PV and ensures the company complies with changing requirements through updating procedures and practices as appropriate.
• Ensures compliance with current legal obligations and guidelines and other industry standards relating to PV
• Supports on aggregate reports, e.g., PSUR (PBRER) and DSUR, from medical perspective
• Upon request oversees the set-up of all new studies including the preparation of study specific SAE processing documents and Safety Management Team (SMT).
• Performs other related duties as assigned or requested by the Vice President PV/EU QPPV

Required education:

• A Doctor of Medicine (MD) degree
  

Complementary training & knowledge of applications:

• Excellent knowledge 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
• Good knowledge of GCP/ICH guidelines
• Experience in planning, allocating and managing multiple projects.
• 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.
• Computer proficient

Required experience:

• Minimum 4+years of solid and proven industry experience in pharmacovigilance and drug safety, both for Medicinal Products under development and marketed MPs
• roven experience in leading a global team

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

• A highly competitive salary
• 8.33% holiday allowance (for NL)
• A minimum of 30 vacation days
• Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all "Pharmers".

Also important We truly value a healthy life-work balance with a lot of flexibility.

Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you

We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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