Senior QA Manager Pharmacovigilance

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team. Due to this growth my client is looking for a Senior QA Manager Pharmacovigilance to join their team on a permanent contract based near Lausanne. The person will have an overview and assessment of GVP activities to ensure robust systems and processes for global Pharmacovigilance activities.

Your Responsibilities

  • Lead execution of the Global Pharmacovigilance audit program
  • Lead the maintenance of the Pharmacovigilance Quality Management System including QA support for Pharmacovigilance supplier qualification, risk management, change control, deviations, review of SOPs with ensuring continuous process improvement
  • Establish robust collaboration with PhV Leaders, including EU-QPPV.
  • Reviewing key pharmacovigilance documents, e.g. PSMF, reports, and regulatory submissions.
  • Assist in preparing, coordinating and hosting Inspections/Partner audits in collaboration with the Pharmacovigilance function.
  • Support the development of the Pharmacovigilance training program in collaboration with Pharmacovigilance group.
  • Coordinate responses and corrective/preventative actions from deviations, audits and regulatory inspection findings.
  • Stay abreast of Pharmacovigilance and Safety regulations, EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
  • Escalate to Global QA Clinical/ Pharmacovigilance Management of internal and external serious non-compliance/deviations in a timely manner.
  • Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned.

Your Profile

  • Minimum Bachelor's degree in a science or healthcare related discipline, or similarly conferred degree from a University
  • 3 - 10 years' experience in a pharmaceutical or bio-pharmaceutical company in a PV QA role with a minimum of 2 years’ lead auditor experience performing GVP compliance audits of vendors and business partners.
  • Ability to travel a minimum of 30%.
  • Prior GVP I GCP inspection experience preferred.
  • Thorough knowledge in cGCP and cGVP and global regulatory requirements;
  • Experience in managing Audit contractors
  • Strong Interpersonal skills, including organizational sense, rational and autonomy
  • Strong verbal and written communication skills with well-structured communication and presentation ability;
  • English fluency written and spoken (the company language);
  • Results focused which may require negotiating skills and diplomacy,

For further information, please contact: Noemie Oliva: noliva@axepta.com

Noemie OLIVA

Noemie OLIVA

Team leader & Recruitment Manager Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Senior QA Manager Pharmacovigilance

Jul 13, 2021Senior QA Manager PharmacovigilanceRégion Lausanne Full Time Permanent Job noliva@axepta.com Life Sciences

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