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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)
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.