Senior Pharmacovigilance Compliance Specialist
3 weeks ago
As 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 3 years of pharmacovigilance, drug development, clinical development or regulatory affairs experience specifically involving Safety Database case processing.
Responsibilities Include:
- Providing compliance oversight through ongoing monitoring of safety outputs created by WWPS to ensure continuous compliance and quality excellence with all applicable safety guidelines and regulations.
- Ensuring ongoing regulatory compliance and mitigation of potential risks associated with PV activities delivered by WWPS.
- Collaborating with local and global compliance and quality leads for continuous compliance improvement by ongoing communications regarding any quality trends and reinforcement of process.
- Maintaining in-depth knowledge of global pharmacovigilance regulations that impact the research, development and marketing of medicines and devices as well as relevant Bristol-Myers Squibb Company policies and procedures.
- Escalating any suspected compliance, quality concerns or potential risks associated with in-house or outsourced Pharmacovigilance activities to the head of PV Compliance.
Requirements
- Degree in healthcare science such as B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent.
- A minimum of 5 years pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development or regulatory affairs experience specifically involving Safety Database case processing.
- Prior experience in IT project management including the skills for JIRA management, HP ALM, and share point management is preferred.
- Strong scientific background in a life science related field.
- Prior quality related experience in pharmacovigilance preferred.
What We Offer
- Unique and challenging work opportunities in a dynamic and inclusive environment.
- Opportunities for professional growth and development.
- Competitive compensation and benefits package.
- Recognition and rewards for outstanding performance.
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