Manager, PV Audit

Bristol Myers Squibb

5 - 10 years

9 - 13 Lacs

hyderabad

Posted:17 hours ago| Platform:

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Skills Required

medical affairs manager quality assurance document review gcp analytical pharmacy clinical trials life sciences pharmacovigilance licensing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.
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.
Maintain expertise in country-specific and global PV regulations and guidelines.
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, as required).
Additional Quality activities as assigned.

Qualifications & Experience

Degree/ Certification/ Licensure:

Bachelor s degree in pharmacy, Medicine or Life Sciences or equivalent experience.

Experience- Responsibility and minimum number of years:

A minimum of 5 years experience in Pharmacovigilance/Regulatory Affairs/Clinical Safety/Medical Affairs.
Quality Assurance/Compliance and PV Auditing experience 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 5 years in the pharmaceutical industry or equivalent.
Demonstrated 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.
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.
Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.

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