Associate Director, Pharmacovigilance Auditing

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Position Summary

The Associate Director of PV Audits is responsible for ensuring compliance with pharmacovigilance (PV) regulations and guidelines. This role involves conducting audits of PV systems, processes, and third parties to ensure the safety and efficacy of BMS’ pharmaceutical marketed products.

Key Responsibilities:

• Lead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System (including Critical processes, Affiliates, Licensing Partners, Service Providers/Vendors, Distributors, and NI PASS) to ensure compliance with regulatory requirements, company procedures and contractual arrangements.

• 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;

• Conduct risk assessments for specific audit types in line with regulatory requirements and expectations (as applicable).

• Provide input in the global audit plans based on identified signals/trends/risks/gaps;

• Provide training on pharmacovigilance regulations and guidelines to internal teams and external partners as needed.

• Maintain expertise in country-specific and global PV regulations and guidelines.

• Develop, deliver and support training needs for junior auditors

• Serve as a subject matter expert on PV related topics and advise on regulatory, clinical safety/ pharmacovigilance related matters;

• Establish strong partnership with business stakeholders.

• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems

• Support inspection activities (i.e. mock interviews, document review, back room support, hosting, as required.

Qualifications & Experience:

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

• Extensive experience in Pharmacovigilance/Regulatory Affairs/Clinical Safety/Medical Affairs.

• Quality Assurance/Compliance and PV Auditing experience preferred or equivalent combination of education, training and experience in Pharmacovigilance.

• Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities of at least 8 years in the pharmaceutical industry or equivalent.

• Minimum of 5 years in Clinical, Medical, Pharmacovigilance or Regulatory Quality.

• Demonstrated strong knowledge of global PV legislation and guidance, medical affairs and regulatory processes and principles of Quality Assurance.

• Demonstrated applied knowledge of pre-and post-marketing regulatory requirements,

• Analytical, organizational and planning skills.

• Broad knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.

• 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 que