Hendre Moolman at CK Clinical is currently recruiting for a Pharmacovigilance Audit Lead to join an established biopharmaceutical company in Surrey.
As Pharmacovigilance Audit Lead, you will implement the QA risk-based audit programme and lead independent global pharmacovigilance audits. You will have the opportunity to perform audit metrics and root-cause analyses of non-compliances and provide guidance, train and support business partners. You will review and advise on pharmacovigilance related policies, Standard Operating Procedures and Internal Procedures.
- Manage the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.
- Lead, plan, perform, conduct, follow-up and document global quality regulatory compliance audits and assessments of pharmacovigilance and safety reporting practices within the company.
- Perform activities with a high degree of independence. Provide technical guidance, leadership, coaching and training of other auditors on audit related activities.
- Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit. Perform timely management of audit metrics and root cause analysis of non-compliances.
- Monitor and track status of corrective and preventive actions to ensure that the issues are adequately addressed and completed.
- Provide leadership to drive closure of audits through close collaboration with auditees, involved business units and partners.
- Prepare routine over-view of outstanding CAPA (Corrective Action Preventive Action) items.
- Identify and communicate quality and regulatory compliance issues to DS&E QA management and DS&E management through appropriate channels. Lead heavyweight initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; and provide on-going project support and governance, as assigned.
- Prepare for, facilitate and lead logistics for local and global Health Authority (HA) PV inspections; assess results of pre-inspection preparation activities and HA inspection findings in terms of associated risks and communicate to management; provide input to CAPA to ensure quality, consistency and appropriateness of commitments.
- Interface and communicate with regulatory authority representatives as required.
- With a high degree of independence, evaluate audit and assessment results, identify specific regulatory, compliance and quality assurance training needs for global business partners and lead initiatives to develop, implement and conduct appropriate training.
- Utilise professional competence to support DS&E with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement.
- Analyse root causes for non-compliance through process review.
- Identify issues and recommend conduct of formal investigations; sign-off investigations.
- Review, advise and approve relevant local and global guidelines, policies, Internal Procedures and SOPs.
- Proactively research local and global initiatives, trends and events that impact maintenance of compliance.
The ideal candidate:
Hendre is looking for candidates with the following skills, experience and qualifications:
- Proven PV/clinical/industry/health authority experience with GCP/PV auditing experience;
- Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision;
- Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;
- Extensive experience with Health Authority inspections and interaction;
- Excellent quality and compliance leadership and facilitation skills;
- Excellent computer skills, including Excel, Word;
- Extensive knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures;
- Good knowledge of computer validation and Part 11 requirements;
How to apply:
For more information or to apply for this Pharmacovigilance Audit Lead, please contact Hendre on 01438 870 023 or email firstname.lastname@example.org. Please quote reference CL23007 in all correspondence.