Senior Manager, Pharmacovigilance Auditing

Senior Manager, Pharmacovigilance Auditing

Senior Manager, Pharmacovigilance Auditing

Location: Remote - United Kingdom, Belgium, Ireland, Switzerland

Time Type: Full time

Posted: 7 Days Ago

Position Purpose

The Senior Manager, Pharmacovigilance (PV) Audit is responsible for ensuring compliance with PV regulations and guidelines. This involves conducting audits of PV systems, processes, and third parties to ensure the safety and efficacy of Bristol Myers Squibb's pharmaceutical marketed products.

Key Responsibilities

• Lead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System.
• Audit types will include Critical processes, Affiliates, Licensing Partners, Service Providers/Vendors, Distributors, and NI PASS.
• Document audit findings and prepare detailed audit reports in line with procedural timelines.
• Escalate concerns and provide expert guidance on PV compliance issues.
• Support and advise on the development of appropriate corrective and preventive actions.
• Proactively manage findings, responses, and CAPA arising from audits in the BMS Quality Management system.
• Review the effectiveness of actions to address audit findings.
• Provide input in the global audit plans based on identified signals/trends/risks/gaps.
• Maintain expertise in country-specific and global PV regulations and guidelines.
• Serve as a subject matter expert on PV-related topics and advise on regulatory, clinical safety/pharmacovigilance related matters.
• Actively share knowledge with others across multiple disciplines and through existing knowledge sharing processes and systems.
• Support inspection activities (i.e., mock interviews, document review, back room support).

Required Qualifications

• University Graduate in Pharmacy, Medicine, or Life Sciences or equivalent experience.

Required Experience & Competences

• Experience in Pharmacovigilance, Regulatory Affairs, and/or Clinical Safety.
• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
• Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data.
• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.

Required Knowledge

• Demonstrated expertise of clinical safety and pharmacovigilance, and/or regulatory affairs.
• Demonstrated knowledge of global PV legislation and guidance, and principles of Quality Assurance.
• Analytical, organizational, and planning skills.

Ideal candidates will have

• Quality Assurance/Compliance and PV Auditing experience preferred or equivalent combination of education, training, and experience in Pharmacovigilance.
• Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers.