Director, PV & QPPV

Director, PV & QPPV

Zogenix

Dublin, Ireland

POSITION SUMMARY

We are currently looking to hire a Director PV & QPPV. This is an exciting opportunity to join Zogenix and to support the European launch of the company’s first commercial product along with providing support for other business objectives. The Director, PV & QPPV role will help Zogenix establish a high performing Pharmacovigilance organization. The role will be based in office in Dublin, Republic of Ireland and report into the VP, Safety & Pharmacovigilance who is based in Emeryville.

KEY RESPONSIBILITIES

QPPV Responsibilities

  • Development and maintenance of the Master file of the pharmacovigilance system (PSMF), overseeing it’s content and maintenance, and ensuring the availability of the PSMF to Competent Authorities (CA).
  • Is the Primary Company contact for EMA and EU country competent authorities on a 24/7 basis, for issues involving the safety of the company’s products and ensures that the back-up is available and fully informed about current drug safety issues in case of her/his absence.
  • Maintaining Quality Management System related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), associated Work Instructions (WIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed to ensure alignment with global SOPs.
  • Ensuring timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.
  • Management of the PV compliance and audit function to ensure compliance from internal stakeholders and external business partners.
  • Responsible and accountable for conduct of continuous overall pharmacovigilance evaluation of the company’s products authorized in the EU. Maintains an overview of the benefit risk profile and any emerging safety concerns and has an obligation to inform the Competent Authorities, when a public health concern is identified.
  • Responsible and accountable for compliance of expedited and periodic reporting as well as the quality of the reports (ICSRs, PSURs, reports on company-sponsored post-authorization safety studies) to be submitted to the EU Competent Authorities.
  • Ensures full, prompt and accurate response to any request from the EU Competent Authorities and notification of emerging safety issues.
  • Is the contact for Pharmacovigilance Inspections which are conducted in the EU.
  • Responsible for establishing and maintaining all QPPV governance procedures and mechanisms to allow the sponsor’s QPPV Network to always meet mandated regulatory obligations world-wide.

Pharmacovigilance

  • Develop Regional Strategic Plans and Objectives;
  • Develop proactive risk management strategies for marketed and/or investigational compounds;
  • Contribute to a full range of pharmacovigilance (PV) activities for investigational product and marketed products, including operational activities, cross-functional activities with other departments (e.g., Biometrics, Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Sales & Marketing), Quality Systems, Audits and Inspections;
  • Provide updates of the assigned drug's safety profile to Senior Management and recommend pharmacovigilance/risk management activities to corporate decision-making bodies, as applicable.
  • Contribute to and review investigator's brochures, safety sections of clinical study protocols, single and aggregate expedited reports, development safety update reports, Periodic Benefit-Risk Evaluation Reports/PADERs, clinical overview statements, and risk management plans.
  • Contribute to and review MAA-related safety documentation.
  • Ensure the right capabilities and training to secure adequate Pharmacovigilance oversight and activities within Europe.
  • Oversight of Vendor activities within PV.
  • Surveillance/signal detection activities.
  • Develop an adequate communication structure to include relevant functions both in Europe and Globally.
  • Suggest and develop relevant Pharmacovigilance processes and supporting SOPs as required.
  • Authoring and/or review of Risk Management Plans and educational materials.
  • Other Duties as Required.

Knowledge, Experience & Skills

  • MD qualified.
  • 7+ years of experience in pharmaceutical industry, preferably neuroscience and/or epilepsy and/or rare diseases.
  • Strong background in Pharmacovigilance/QPPV on a European level.
  • Substantial experience from pharmaceutical industry, preferably neuroscience and/or epilepsy and/or rare diseases.
  • Broad understanding of healthcare delivery environment, and the role of the pharmaceutical industry.
  • Comprehensive understanding of Industry Medical and Financial governance norms, with particular reference to compliance with all European laws, regulations, and codes of scientific and promotional Practice.
  • Effective collaboration across cross-functional and geographical boundaries.

Key competencies

  • Demonstrated leadership ability.
  • Proven flexibility and adaptability with cultural astuteness and sensitivity.
  • High ethical standards and able to work with transparency and Openness.
  • Sound organizational skills to manage multiple projects simultaneously.
  • Strong written and verbal communication skills along with excellent judgment and ability to work in a team environment.
  • Proven ability to work across a cross-functional matrix.
  • Self-starter with “can do” attitude.
  • Knowledge of budget and account management.
  • Able to travel to domestic and International conferences.
  • Regular travel to European Headquarters in Maidenhead, UK is required.
  • Fluency in English is required. Other languages a plus.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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