Senior Director Pharmacovigilance

2 weken geleden

nederland Pharming Group Voltijd

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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:
The Senior Director Pharmacovigilance is responsible for the global safety strategy and overall safety profile for the assigned Pharming products throughout their lifecycle. This includes leading all major pre-and post-marketing safety related deliverables involving, safety evaluation, benefit-risk evaluation, and risk management activities.
This individual will work together with other drug safety team members in overseeing processing of (S)AE reporting, management of the processes for all (S)AE data and responses to safety requests from Competent Authorities worldwide. This includes:
review of the individual, aggregate and scientific literature of Adverse events, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders.
This individual must effectively interface cross-functionally within the organization as well as with external Competent Authorities. 
The Senior Director will also manage the Director and PV Manager(s) and Associate(s) to ensure successful performance. 
 

  • Support the Vice President PV/EU QPPV.
  • 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.
  • Performs ongoing surveillance of safety data for Pharming products.
  • Ensures handling of safety issues and implementing of risk mitigation activities
  • 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.
  • Oversees collection and collation of 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 a 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; clinical research and/or fellowship training in pharmacology or other relevant specialty is a plus.


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 8+ years of solid and proven industry experience in pharmacovigilance and drug safety, both for Medicinal Products under development and marketed MPs
  • Experience leading a team of physicians and /or scientists at a global level.
  • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries
  • Strong knowledge of individual adverse event case reporting process, triage and medical review
  • Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred.
  • Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position.

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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