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Quality Assurance Pharmacovigilance Specialist

Ref: JN-042022-254477

Publié le 13 April 2022
Catégorie
Sciences de la vie

we are recruiting, on behalf of our client, an experienced Quality Assurance Specialist with a focus on pharmacovigilance activities.

Are you looking for a new opportunity? are you motivated to join a dynamic growing team and have a direct impact on the distribution of pharmaceutical products?

Our client is offering an exciting working environment and nice benefits!

Join us to apply for this role!

Main purpose of the role:

This responsibility for the pharmacovigilance specialist means that the QPPV has oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance) inspections, to mention some but not all.

Responsibilities:

At this role you will be :

  • The focal point for the authorities, customers, and suppliers
  • Identify, assess and manage risks, provide reports on key risks and issues
  • Investigate and provide quality reports
  • Audit suppliers

Duties:

  • Develop a robust pharmacovigilance quality system and be the responsible person for the entire QMS in the relevant areas/aspects i.e. pharmacovigilance.
  • Act as the sole responsible for pharmacovigilance compliance with the Swiss and EU laws, rules and regulations and local SOPs, also for external contractual partners, including training of the safety team and SOP maintenance.
  • Ensuring submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP, ensuring the necessary quality, including the correctness and completeness of data submitted to the competent authorities
  • Having an overview of medicinal product safety profiles and any emerging safety concerns
  • Monitor and assess safety processes and procedures for consistency and compliance with Swiss Medic, Swiss Laws and EU regulations, regulatory requirements and internal policies and procedures
  • Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products. In addition, having awareness of risk minimization measures; manage the further development and implementation of a risk-based PV Audit program (including audits of Affiliates, Distributors, Contractors)
  • Monitor deviations, escalate as necessary and maintain CAPA oversight for all audits and
  • Inspections
  • Being aware of and having sufficient authority over the content of risk management plans
  • Lead the preparation, host and follow up on Regulatory Authorities inspections related to
  • Pharmacovigilance
  • Being involved in the review and sign-off of protocols of post-authorization safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU;
  • Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)

Profile:

  • Bachelor’s degree preferred in health/life sciences, pharmaceutical sciences or health related field
  • Sound knowledge and experience from 4-6 years in Pharmacovigilance (as QPPV), experience in trade company is highly desired
  • Experience in the development of a PV Quality Management System
  • Quality inspection, auditing and testing experience as well as experience with CAPA - Corrective Action/Preventive Action and experience in Change Controls (2 to 5 years plus experience in PV auditing with EU/FDA /global regulatory requirements desired)
  • Solid knowledge and practical experience in procedures for assessing complaints and non- conformities
  • Quality Auditor, Quality Engineer, Quality Improvement Associate certifications are highly desired.
  • ISO, GMP (Good Manufacturing Practices) and experience with SwissMedic registration process and regulations
  • Profound knowledge and understanding of Swiss regulations with regard to
  • pharmacovigilance practices for medicinal products and medical devices. Very good knowledge of ICH (GCP) and EU Good Pharmacovigilance Practices (GVP), highly desired
  • Knowledge of drug development process within a regulatory environment
  • Strong computer skills including Microsoft Office, QA applications and databases
  • Knowledge of tools, concepts and methodologies of QA
  • Solid experience in effective use of data analysis tools and statistical analysis

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