European Qualified Person for Pharmacovigilance (EU-QPPV)

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. 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 Qualified Person Responsible for Pharmacovigilance (EU-QPPV) plays a critical role in ensuring the safety and efficacy of medicinal products within the European Economic Area (EEA). In compliance with European Union legislation (Directive 2001/83/EC, as amended, Article 1043(a), and the Guideline on Good Pharmacovigilance Practices, GVP Module I, Section I.C.1.1), the Marketing Authorization Holder (MAH) is mandated to appoint a permanently available, suitably qualified individual to fulfill this position.
 

Reporting to the VP of Global Pharmacovigilance (with ‘dotted line’ reporting to the Chief Medical Officer) the key responsibilities of the QPPV include:

• Act as a single pharmacovigilance (PV) contact point for the European Medicines Agency (EMA) or National Competent Authorities (NCAs) in the EEA on a 24/7 basis, and act as a contact point for PV inspections

• Establish and maintain the Pharming pharmacovigilance (PV) system

• Ensure and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the PV system under the QPPV’s responsibility.

• Maintain oversight over the functioning of the global system of PV in all relevant aspects, including its quality system (e.g., Key Performance Indicators (KPIs), standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance). 

• Be aware of the validation status of the Global Safety Database and be informed of significant changes that are made to the database.

• Ensure the preparation and timely submission of individual safety reports and aggregate reports (e.g., Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR).

• Have an overview of the safety profiles and any emerging safety concerns for Pharming’s MP(s).

• Ensure the conduct of regular, ongoing evaluation of benefit-risk of Pharming’s MP(s) during the post-authorization period, e.g., by overseeing signal management; and the creation and maintenance of Risk Management Plans (RMPs) and any associated risk management commitment.

• Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals).

• Be involved in the review and sign-off of protocols of post-authorisation safety studies
  conducted in the EEA or pursuant to a risk management plan.

• Review and approval, as required, of regulatory submissions including, but not limited to, RMPs, aggregate safety reports and safety labelling changes.

• Have awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products

• Have awareness of, and input in to, risk minimisation measures and any associated measure of effectiveness.

• Have oversight of local contact persons for PV in EEA countries and the UK, as required

• Liaise with Pharming’s Quality Assurance group as a lead role for GVP inspections and inspection readiness.

• Highlight potential quality deficiencies in the PV system, including those associated with external partners and internal stakeholders, to Quality Assurance with a view to remedial action or audit.

• Ensure that the Deputy QPPV, and any other supporting role, is suitably trained and informed.

• Ensure that any request from the EMA or NCAs in the EEA for the provision of additional information necessary for the evaluation of the benefits and risk of any Pharming MP is answered fully and within the deadline, in cooperation with Pharming’s Global Regulatory Affairs (GRA) and other departments, as applicable.

• Ensure, in cooperation with GRA, that NCAs in the EEA or EMA are promptly provided with any new information arising that may impact the benefit-risk balance of any authorized Pharming MP, including appropriate information from post-authorization safety studies (PASS).

• Contribute to SMT/Safety Committee meetings as a quorum member.
   

Knowledge:
Required education:

• A degree in medicine or postgraduate qualification in a medical science is an advantage but not a requirement in lieu of extensive experience of quality management in PV

Complementary training & knowledge of applications:

• Solid understanding with the applicable EU legislation and EMA Guidelines on Good Pharmacovigilance Practices (GVP) Modules
• Knowledge of international standards for PV (i.e., GCP/ICH guidelines)
• Knowledge of the key QPPV PV activities
• Ability to interpret safety data associated with signal generation, aggregate reporting, studies and epidemiology literature.

Required experience:

• Minimum 5+years of solid and proven industry experience in pharmacovigilance and drug safety, both for Medicinal Products under development and marketed MPs
• Previous experience in a QPPV (or Deputy QPPV) role

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
• An excellent pension plan
• 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.