Senior Manager, PV Compliance and Quality

Welcome to Bristol-Myers Squibb, a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines to patients battling serious diseases. We are seeking an experienced and highly skilled Senior Manager to join our Pharmacovigilance (PV) Compliance and Quality team. As a key leader in our organization, you will play a critical role in ensuring the safety and quality of our products, ultimately impacting the lives of patients worldwide. Our ideal candidate is a proactive and detail-oriented individual with a strong background in PV compliance and quality management. If you are passionate about making a difference in the healthcare industry and possess the necessary qualifications, we invite you to apply for this exciting opportunity.

Responsibilities:

1. Oversee all PV compliance and quality activities within the organization, ensuring adherence to global regulations and company policies.
2. Develop and maintain a comprehensive PV compliance and quality program, including policies, procedures, and training materials.
3. Lead PV compliance and quality audits, both internal and external, and ensure timely resolution of any identified issues.
4. Collaborate with cross-functional teams to implement corrective and preventive actions to address compliance and quality gaps.
5. Monitor and analyze PV compliance metrics to identify trends and areas for improvement.
6. Stay current with industry developments and regulatory requirements related to PV compliance and quality, and communicate updates to relevant stakeholders.
7. Provide guidance and support to PV team members on compliance and quality matters.
8. Serve as a subject matter expert for PV compliance and quality during regulatory inspections and interactions.
9. Conduct risk assessments to identify potential compliance and quality risks and develop strategies to mitigate them.
10. Lead and participate in cross-functional projects related to PV compliance and quality.
11. Collaborate with external partners, such as vendors and clinical research organizations, to ensure compliance with PV requirements.
12. Develop and maintain effective relationships with regulatory agencies and participate in industry forums to stay informed of best practices.
13. Develop and maintain strong relationships with internal stakeholders, such as medical affairs, clinical development, and regulatory affairs, to ensure alignment on PV compliance and quality initiatives.
14. Participate in the development and review of safety-related documents, including protocols, investigator brochures, and periodic reports.
15. Mentor and train junior PV team members on compliance and quality requirements and best practices.
16. Continuously assess and improve the PV compliance and quality program to meet changing business needs and regulatory requirements.

According to JobzMall, the average salary range for a Senior Manager, PV Compliance and Quality in Hyderabad, Telangana, India is between ₹1,800,000 - ₹2,400,000 per year. This equates to approximately $24,000 - $32,000 in USD. However, this can vary depending on the specific company, industry, and individual's experience and qualifications.

Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.