Senior Director & EU QPPV

Senior Director & EU QPPV

Ascendis Pharma

Hellerup, Denmark

We are currently looking to hire a Senior Director, Qualified Person for PharmacoVigilance (QPPV) to cover EU. This is an exciting opportunity to join the Pharmacovigilance function at Ascendis and to support the European launch of the company’s first commercial product along with providing support for other business objectives. The Sr Director, QPPV role will help Ascendis establish a high performing Pharmacovigilance organization. This role will report into the Vice President of Pharmacovigilance and Global Drug Safety, who is based in Palo Alto, California, USA.

As Senior Director & EU QPPV you will provide oversight of adverse events processing, safety data management, the Pharmacovigilance Master File (PSMF), and safety exchange agreement activities and fulfill the role of QPPV for the EU. Furthermore, the role may also lead a Patient Safety Team for assigned Ascendis’ investigational compounds and marketed products.

The QPPV must be a resident within EU (preferably in Copenhagen, Denmark).

KEY RESPONSIBILITIES:

  • To influence and oversee the performance of the pharmacovigilance system. The MAH shall ensure that the QPPV has sufficient authority to influence the performance of the quality system and pharmacovigilance activities of the MAH;
  • Development and maintenance of the Master file of the pharmacovigilance system (PSMF), overseeing its 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 their absence;
  • Ensuring that any delegation of specific tasks to appropriately qualified and trained individuals is documented;
  • Oversight of the 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 PV deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate;
  • 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;
  • Informed on labelling issues that have a potential safety impact and consulted;
  • 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;
  • Supporting the head of global safety to oversee and implement appropriate PV processes and compliance monitoring;
  • Maintains understanding of and ensures compliance of SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process;
  • Participates in audits/inspections and always ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventative actions;
  • Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug safety, pharmacovigilance, and product registration;
  • Train Ascendis colleagues about regulations and guidance;
  • Other duties as assigned.

Knowledge, Experience & Skills

  • Holds a relevant academic degree in medicine (MD preferred), pharmacy, or the life sciences;
  • 7+ years of experience in pharmaceutical industry;
  • Strong background as a QPPV on a European level;
  • Proven understanding and practical experience of all aspects of PV including ICSRs, safety signals, aggregate reports, quality management system, audits & inspections, safety database at both the central and regional level;
  • Comprehensive understanding of Industry Medical and Financial governance norms, with 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;
  • Must have demonstrated people leadership capability (span and depth);
  • Strategic and tactical mindset to meet the objectives of the Global Safety Leadership Team and company initiatives;
  • Knowledge of budget and account management;
  • Able to travel domestically and internationally;
  • Fluency in English (both verbal and written) is required;
  • Proficient with computer skills, including Microsoft Office Applications (Word, Excel, Power Point and Project, preferred).

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© EuroJobsites 2022

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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