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Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Senior Director, EU QPPV

Department: Pharmacovigilance
Location: Incyte Biosciences Distribution B.V.

Summary

The Senior Director, Qualified Person for Pharmacovigilance, European Union (QPPV EU), is responsible for providing the legal framework for pharmacovigilance of medicinal products for human use in the European Union. In summary, the QPPV EU is responsible for establishing,  maintaining, and managing the Marketing Authorisation Holder’s (MAH’s) pharmacovigilance (PhV) system, ensuring the PhV system is appropriately described in the PhV System Master File (PSMF), and having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which Incyte holds marketing authorizations. This position reports to the Vice President (VP), Global Pharmacovigilance and Risk Management.

Duties and Responsibilities 

  • Serves as the Qualified Person responsible for Pharmacovigilance (QPPV) in the EU, residing in the EU/European Economic Area (EEA), and fulfills the role of QPPV EU as defined in the current legislation and guidances.

  • Acts as a single contact point for PhV for the EU Competent Authorities and European Medicines Agency (EMA) on a 24/7 basis and also as contact point for PhV inspections in the EU/EEA.

  • Maintains an overview of the safety profiles and emerging safety concerns of Incyte products with a marketing authorization application (MAA) or a marketing authorization (MA) in the EU/EEA, through:

    • Active involvement in risk management and evaluation activities through either attendance at or receipt of agendas and minutes for Safety Review Committee meetings, Incyte Safety Review Board meetings, and core labeling review meetings.

    • Review and approval of regulatory communications, analyses, or reports for product(s) with an MAA or MA in the EU/EEA, including, but not limited to, aggregate reports such as Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), and EU Risk Management Plans (RMPs).

    • Review and sign off on regulatory action in response to emerging safety concerns such as those that result in labeling changes in the EU, safety related variations, urgent safety restrictions, or Direct Healthcare Professional Communications.

    • Review, provision of input, and approval of safety-related responses to regulatory enquiries from EU agencies, ensuring they are answered fully and in a timely manner.

    • Participation in decision making process for appointment of deputy QPPV.

  • Maintains oversight of the pharmacovigilance system applicable to products with an MAA or MA in the EU/EEA, through:

    • Review and provision of input to PhV policies and procedures, including business continuity plans and interdepartmental or other functional area SOPs, as appropriate.

    • Review and approval of the pharmacovigilance system master file (PSMF)

    • Review of applicable performance measures for PhV (including applicable PhV vendor activities) the PhV audit program, PhV-relevant audit reports and corrective and preventive action (CAPA) plans

    • Overseeing local PhV activities through input to local PhV processes and regular contact with local responsible PhV persons, where there is a functional reporting line into the QPPV EU

    • Involvement in preparation of applicable contractual arrangements with external service providers, distributors, and business partners.

    • Awareness of activities associated with the validated safety database, including significant changes associated with the database (e.g., changes that could have an impact on PhV activities) as well as validation failures and corrective actions to address failures as appropriate.

    • Review of training curricula for PhV staff

  • Provides advice to Global Pharmacovigilance and Risk Management and to Regulatory Affairs with respect to Post Authorization Safety Studies (PASS) as required. Reviews and approves PASS protocols for studies conducted in the EU or pursuant to a risk management plan agreed in the EU. 

  • Maintains qualification for the position by attendance at suitable conferences and/or benchmarking with other pharmaceutical companies and/or attending meetings with regulators and/or working groups that monitor and influence European legislation.

  • Ensures oversight as required within the Global Pharmacovigilance and Risk Management organization to deliver full compliance with territorial regulatory safety requirements for non-EU/EEA territories for which Incyte Europe has responsibility (e.g., Switzerland, Israel, Turkey, and other countries of the territory under EMEA responsibility).

Requirements

  • Medical physician (M.D. or equivalent) with a minimum of seven (7) years’ experience in the pharmaceutical/biotechnology industry in pharmacovigilance/drug safety

  • In-depth knowledge of Good Clinical Practice and Good Pharmacovigilance Practice

  • Excellent understanding of drug development and life-cycle management of medicinal products

  • Experience in conducting individual case reviews for expedited safety reporting

  • Experience analyzing clinical case series for the purposes of aggregate safety reporting, signal detection, issue management, and responding to queries by regulatory authorities for both clinical and postmarketing products

  • Experience as an active contributor to EU submission dossier (Clinical Study Reports (CSRs), Clinical Overview, Renewal)

  • Minimum of three (3) years of post-graduate clinical experience in academic or private practice including a hospital based setting, preferably in oncology

  • Advanced knowledge of pre-and post-marketing US, EMA, and worldwide safety regulations

  • Prior experience as EU QPPV for a pharmaceutical or biotechnology company with active clinical research and development

  • Experience in developing and executing risk management strategies (e.g., Risk Management Plans, risk minimization measures, monitoring of adverse events of special interests)

  • Fluent in written and spoken English

  • Ability to communicate effectively (cross-functionally and within the function) to create a positive and productive working environment

  • Ability to travel as needed
     

Highly Preferable (but not an absolute requirement):

  • M.P.H. or relevant epidemiology experience in industry or academia

  • Board certification in Internal Medicine or Pediatrics (primary care) or Hematology/Oncology (specialty)

  • Training or experience in oncology or inflammatory diseases, or clinical safety support of oncology, immunomodulatory therapies, or other related products

 

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