• Permanent Position
  • Basel/NW Region
  • Recruiter: Lhackdon Beck

The Life Science Career Network 

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.  

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a for a permanent role based in Basel area for a: 

Senior Pharmacovigilance QA Manager (4969) 

Main Responsibilities:

This role within the Pharmacovigilance (PV) QA team is key to deliver high quality audits across the globe covering all aspects of a fully functional PV system including interactions with other pharmaceutical companies, service providers and distributors. 

  • Execute a risk-based, global PV QA audit program covering internal (PV system, affiliates) and external (service provider, licensing/marketing partner, distributor) audits to verify adherence to the PV system: Independently leads the planning, conduct and reporting of routine and non-routine Pharmacovigilance audits of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, complex/sensitive system/service provider audits as defined by the scope.  
  • Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
  • Ensure that corrective/preventive actions have been identified, documented and are effective. Provides expert support to auditees when developing CAPAs. Influence consistency of CAPAs for similar issues.
  • Contribute to official escalation of significant PV compliance issues
  • Provides expertise and knowledge to less experienced auditors, internal stakeholders (Global Drug Safety, Global regulatory affairs, Marketing, Medical Affairs, Medical Information, affiliates) on quality and compliance processes/procedures. Interprets and applies regulations/ policies to complex issues in order to influence decisions and actions, when required. Communicates internally to ensure a departmental unified position regarding advice and consultation is provided. 
  • Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.  
  • Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress
  • Participates in regulatory (affiliate and HQ) PV inspections in core and supporting roles during preparation, conduct, reporting and follow up phases
  • Ensures personal compliance with training at all times and contribute/build training materials as needed, for training and/or coaching PV QA staff. Train and coach other PV QA staff.
  • Maintain expert level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.
  • Maintain oversight and review the content of key global and local QS Documents relating to the PV system.
  • Use best (industry) practice to implement and support continuous QA process excellence and improvement activities
  • May serve as deputy for PV QA Lead when requested and may supervise junior auditors and contractors, if required

Qualifications and Experience:

  • Graduate Degree in Pharmacy, or other scientific and health related fields; strong background in Quality Assurance/Compliance
  • Demonstrated audit/inspection experience as PV auditor/inspector
  • Expert level of International (primarily, EU, US regulations & ICH guidelines) Pharmacovigilance Regulation knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues. 
  • In-depth knowledge of pharmaceutical industry practices 
  • Approximately 7-10 years of experience in the pharmaceutical industry/health authority within PV.
  • Excellent communication (verbal and written), interpersonal skills
  • Investigation, problem solving, risk analysis & management, negotiation and influencing skills
  • Experienced in the training of employees on GVP requirements and pharmaceutical industry practices 
  • Prior experience hosting/supporting Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.g. FDA, EMA, MHRA, ANSM, BfArM 
  • Experience in international cross-cultural relations
  • Ability to travel at least 20% of the time
  • Fluent in English – knowledge of second language would be advantageous

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.