CLS Services

Gepubliceerd: 15 dagen geleden

PV Process Configuration Manager

Leiden
Gepubliceerd: 15 dagen geleden
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for a PV Process Configuration Manager.

Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.



Job description
As PV Process Configuration Manager, you are responsible for aspects of excellence in Regional PV Process Distribution & Submissions. Reports to the Lead Regional PV Process Distribution & Submissions and contributes to the successful execution of the GPV objectives and 1 -3 year operational plan, supporting the overall GPV mission.
Works extensively with PV Information Management within the region to ensure the quality of outputs as well as system configuration to strengthen the correct functioning of Astellas#39; PV System supporting the ongoing assurance of the safety profile of Astellas products. Acts as a liaison between the teams to translate business requirements into system configuration.

Responsibilities:
Strategy Development and Execution

  • Responsible for implementing, maintaining and improving tools to ensure compliance with regulatory reporting responsibilities (ICSRs as well as other safety reports) and to ensure high quality supporting documentation;
  • Contribute to the successful implementation of annual Regional PV Process Management strategic goals and objectives.


ICSR Processing:
  • Compilation and technical implementation of all regulatory requirements and guidelines from region;
  • Maintain up-to-date oversight and knowledge of all regulatory reporting requirements to Competent Authorities in the region (EMEA: over 100 countries; JP/Asia: appr. 10-20 countries; Americas: appr. 10 countries);
  • Liaise with Global PV Process and line management to explore and identify the possible impact of any new or revised regulations;
  • Maintain up-to-date and complete oversight of regulatory reporting rules and complete oversight of Astellas product information and status in assigned region;
  • Verify regional implementation and maintenance of Business Partner/SDEA specific submission/exchange requirements
  • Build and maintain close relationships with Global PV Information Management.


Quality, Data Assurance & Business Information management
  • Execute reporting compliance QC measures at the regional level to ensure correct technical implementation of ICSR reporting requirements;
  • May represent the Regional PV Process Distribution & Submissions team in Inspections and PV audits;
  • Generate and maintain user requirements for Argus reports and listings, periodic as well as ad hoc;
  • Responsible for QC of such outputs.


Who we're looking for
The ideal candidate has:
  • Minimum BA/BS, preferably with an advanced professional degree;
  • Minimum of 5 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development;
  • In-depth knowledge and understanding of PV Process regulatory reporting requirements and guidelines in assigned region;
  • In-depth understanding of PV, data management and adverse event reporting;
  • Experience in managing multiple projects in a heavily matrixed and/or cross-functional environment.
  • Previous experience in Argus administration or in SQL programming is a plus.


Additional vacancy information
Reference: A2000096
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
WO/MSc.
Terms: Project for at least 1 year.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555

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Fulltime / parttime

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