Senior PV Compliance and Quality Specialist
2 weeks ago
We are seeking a highly skilled and experienced professional to join our team as a PV Compliance and Quality Specialist. In this role, you will be responsible for ensuring the quality and compliance of our pharmacovigilance activities, including safety database case processing, quality monitoring, and compliance with global regulatory requirements.
Key Responsibilities- Perform ongoing monitoring of end-to-end case processing related activities in the global safety database.
- Conduct quality and compliance monitoring activities with respect to safety signals, key medical safety information, and other relevant areas of pharmacovigilance.
- Collaborate with local and global Quality oversight leads, Case Management and Medical Review Teams for continuous quality improvement.
- Communicate suggestions on revising quality monitoring strategies and programs based on results, business risk, external and/or internal feedback.
- Ensure effective communication with key stakeholders and vendors regarding performance metrics and contractual requirements.
- Minimum 5 years pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development, or regulatory affairs experience.
- Strong scientific background in a life science related field.
- Prior quality related experience in pharmacovigilance preferred.
- Excellent communication and interpersonal skills.
- Ability to analyze and interpret complex regulations and develop action plans to optimize compliance.
- Prior experience in IT project management, including JIRA management, HP ALM, and SharePoint management.
- Knowledge of global pharmacovigilance regulations and company policies and procedures.
- Ability to work in a complex, changing environment and be accountable for actions and results.
Bristol Myers Squibb is committed to providing a work environment that is inclusive, diverse, and supportive of our employees' well-being. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
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PV Compliance Specialist
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled PV Compliance Specialist to join our team at Bristol Myers Squibb. As a PV Compliance Specialist, you will be responsible for ensuring the safety of our medicines by monitoring safety outputs and ensuring compliance with global regulatory requirements.Key ResponsibilitiesProvide compliance oversight through ongoing...
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeKey ResponsibilitiesAs a Senior Pharmacovigilance Compliance Specialist at Bristol Myers Squibb, you will be responsible for ensuring the safety of our medicines by ensuring compliance with global regulatory requirements. You will have a strong scientific background in a life science related field and 5 years of pharmaceutical industry experience, including...
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe Senior Pharmacovigilance Compliance Specialist will be responsible for ensuring the safety of our medicines by ensuring compliance with global regulatory requirements. This includes monitoring safety outputs to ensure quality excellence and compliance with worldwide GVP regulations, guidance, and inspectorate expectations.Key...
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Senior Compliance Specialist
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled and experienced Compliance Specialist to join our team at Bristol Myers Squibb. The successful candidate will be responsible for ensuring compliance with global regulatory requirements and ensuring the quality and integrity of our pharmacovigilance activities.Key ResponsibilitiesProvide compliance oversight through...
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Senior Pharmacovigilance Compliance Specialist to join our team at Bristol Myers Squibb. As a key member of our Worldwide Patient Safety group, you will be responsible for ensuring the safety of our medicines and ensuring compliance with global regulatory requirements.Key ResponsibilitiesProvide quality oversight...
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AD PV Systems Specialist
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