9 days ago


Vifor Pharma

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We are currently looking for a Pharmacovigilance Quality Assurance Manager who will conduct the required audits for pharmacovigilance (PV) and support PV Audits and Inspections from Regulatory Authorities and Third Parties. This role will report to and coordinate with the Head of Pharmacovigilance Quality Assurance (PV QA). Your responsibilities will include:
  • Comply with all corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice
  • Independently conduct external & internal audits ( including affiliate, commercial partners, systems and vendor audits)
  • Monitor audit responses and corrective action to ensure accuracy and completeness
  • Auditing of directed and for-cause audits as necessary
  • Audit documentation management and maintenance (including audit logs)
  • Involvement in QM Clinical Medical Regulatory Safety (CMRS) audit CAPA management (tracking, oversight, follow-up)
  • Keep QM apprised of compliance and personnel issues
  • Generate and provide metrics, status and other information in relation with GVP, as required by management
  • Perform other duties as assigned, e.g. GVP training, support of Head QM CMRS, Head PV QA , in Regulatory Authority inspection preparation, conduct and post-inspection activities
  • Provide PV training to staff as well as special training groups from business and sales
  • Write procedures, as well as monitor and assess global safety and clinical processes and procedures for consistency and with global laws, regulatory requirements and Vifor Pharma policies and procedures

The successful candidate has strong interpersonal and communication skills and is able to work independently as well as in a team environment. In addition you will require the following profile:

  • Higher university degree (Masters) or equivalent in a relevant life sciences discipline (health sciences, nursing, pharmacy or related field)
  • Minimum of 5 years of experience in Pharmacovigilance with FDA/EMA/ and ICH/GCP guidelines; monitoring and/or drug safety or clinical operations experience
  • Previous experience in a pharmaceutical company or a Contract Research Organization within Quality Assurance / Compliance
  • Proficiency in standard computer software (Word, PowerPoint, Excel) with a keen interest to database information on electronic systems and databases
  • Fluency in English, both in oral and written communication; other major European language
    (French, German, Spanish or Italian) would be an asset
  • Readiness to travel up to 40%

We are looking for a strong communicator who can interact productively and effectively with peers, management and third parties.  Furthermore, you demonstrate high ethical standards and integrity and proven ability to maintain a high level of confidentiality.  You display flexibility and are able to use resources effectively and reasonably. Finally, your proven experience in a similar position will allow you to be successful in this position and in line with Vifor Pharma values.