Manager, Global Pharmacovigilance Quality Assurance (GVP QA)

Manager, Global Pharmacovigilance Quality Assurance (GVP QA)

Alnylam Pharmaceuticals

Maidenhead, United Kingdom

Quality Assurance Manager, Pharmacovigilance (PV) will be responsible for supporting Quality oversight of Alnylam’s global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support of the development and execution of the GVP audit program as well as contributing to Alnylam’s Inspection activities.

Summary of Key Responsibilities

Manager, PV QA supports all the GVP QA responsibilities as listed below. Different members of the team will have specific focus areas:

  • Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
  • Support cross GxP QA activities requiring PV expertise, as requested.
  • Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
  • Effectively communicate and escalate quality concerns and critical matters to management.
  • Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
  • Develop and maintain processes and tools to support quality audit execution and outcomes.
  • Support PV / post-marketing surveillance inspection readiness and inspection management activities.
  • Support Quality oversight activities for PV and PV related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
  • Develop and report PV QA metrics and dashboards to support Quality oversight.
  • Contribute to Quality or PV initiatives and process improvements, as requested.
  • Other assignments as directed.

Qualifications

  • Educated to university degree (preferably life sciences) or equivalent qualification or experience.
  • Experience in the Pharmaceutical industry in a quality or compliance function, GxP auditing, pharmacovigilance, regulatory affairs, and/or clinical research.
  • Audit skills, and experience of conducting GVP audits is preferred.
  • Knowledge of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2021

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

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

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

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies