Senior Manager, Pharmacovigilance Auditing
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Locations: Remote - United Kingdom, Remote - Belgium, Remote - Ireland, Remote - Switzerland
Time Type: Full Time
Posted on: Posted 9 Days Ago
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Position Purpose
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
1. Lead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System.
2. Audit types will include Critical processes, Affiliates, Licensing Partners, Service Providers/Vendors, Distributors, and NI PASS.
3. Document audit findings and prepare detailed audit reports in line with procedural timelines.
4. Escalate concerns and provide expert guidance on PV compliance issues.
5. Support and advise on the development of appropriate corrective and preventive actions.
6. Proactively manage findings, responses and CAPA arising from audits in the BMS Quality Management system.
7. Review the effectiveness of actions to address audit findings.
8. Provide input in the global audit plans based on identified signals/trends/risks/gaps.
9. Maintain expertise in country-specific and global PV regulations and guidelines.
10. Serve as a subject matter expert on PV related topics and advise on regulatory, clinical safety/pharmacovigilance related matters.
11. Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.
12. Support inspection activities (i.e. mock interviews, document review, back room support).
Required Qualifications
1. University Graduate in Pharmacy, Medicine or Life Sciences or equivalent experience.
Required Experience & Competences
1. Experience in Pharmacovigilance, Regulatory Affairs and/or Clinical Safety.
2. Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
3. Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data.
4. Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.
Required Knowledge
1. Demonstrated expertise of clinical safety and pharmacovigilance, and/or regulatory affairs.
2. Demonstrated knowledge of global PV legislation and guidance, and principles of Quality Assurance.
3. Analytical, organizational and planning skills.
Ideal candidates will have
1. Quality Assurance/Compliance and PV Auditing experience preferred or equivalent combination of education, training and experience in Pharmacovigilance.
2. Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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