Pharmacovigilance Manager (Senior role)
Pharmacovigilance Manager (Senior role)
Bristol Myers Squibb
Job description
Are you ready to take your career in pharmacovigilance and global patient safety to the next step? Explore this Pharmacovigilance Manager role at Bristol Myers Squibb in Hyderabad, Telangana.
Company Description
Bristol Myers Squibb is a global biopharmaceutical firm whose mission is to find, develop and deliver innovative medications that help patients prevail. The company's work encompasses research, clinical development, regulatory affairs and patient safety in its quest to bring novel medications to patients. It fosters collaboration, professional development and continual improvement, while holding firm to scientific excellence and regulatory compliance.
Job Summary
The role is based in Hyderabad and serves the Bristol Myers Squibb Patient Safety organization and its Qualified Person Responsible for Pharmacovigilance (QPPV) support team. The function involves regulatory safety monitoring, aggregate safety report submissions, periodic safety update report coordination and pharmacovigilance documentation. The PV Physician will be responsible for working with internal teams, external stakeholders and service providers to ensure compliance with applicable regulatory standards. The role also involves developing supervision analytics, enhancing operational processes and supporting patient safety operations in overseas markets.
Key Responsibilities
Monitor for safety actions related to BMS-authorized products on health authority websites in the United States, European Economic Area (EEA) and other relevant markets. Document findings and escalate any relevant issues as per established procedures.
Prepare the documentation and submission packages for safety aggregate reports for centrally authorized and non-centrally authorized items in the EEA. Keep records of appropriate documentation and late submissions if required.
Assist in the co-ordination of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) and collaborate with vendors and internal stakeholders as needed.
Support updates to the European Union Reference Date List and follow-up activities to recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC).
Coordinate replies to European Medicines Agency (EMA) assessment reports on established-brand PSURs and PBRERs and communication with external service providers.
Prepare, distribute and preserve the pharmacovigilance summary statement in Module 1.8.1, often known as the QPPV Statement.
Maintain and implement QPPV nomination letter templates, enable dissemination of Investigational Medicinal Product Dossier (IMPD) information to appropriate local-market pharmacovigilance teams throughout the EEA.
Support the creation of analytics for QPPV oversight including safety variation and QPPV notice information.
Partner with Patient Safety colleagues and external stakeholders to discover possibilities for process improvement, workflow automation and enhanced operational efficiency.
Educational Qualification
University degree in health sciences or life sciences or a nursing qualification.
Typically 3 to 5 years experience in pharmacovigilance or a closely related discipline such as regulatory affairs, clinical operations or medical information.
Skills Required
Understanding of pharmacovigilance methods, regulatory safety requirements and pharmaceutical business practices.
Knowledge of PSURs, PBRERs, safety aggregate reports and related regulatory filing activities.
Excellent organizational, co-ordination and stakeholder management skills.
Clear written and verbal communication skills to collaborate with cross-functional teams.
Good problem solving skills, capacity to assess problems, consider wider ramifications and escalate concerns as required.
Analytical skills to examine data flows, prepare oversight information, and detect operational difficulties.
Ability to recognize opportunities for continuous improvement and apply process improvements in a practical way.
Knowledge of Microsoft Office software and ability to deal with other relevant operating systems.
Salary Structure
The average income for a Manager in Pharmacovigilance is between ₹18–₹20 Lakhs per year.
Career Development
This post, as a pharmacovigilance executive, offers the opportunity to further develop your skills in global pharmacovigilance, regulatory compliance and QPPV operations. Experience in managing global safety reporting, stakeholder engagement and process improvements can help future development into senior patient safety, pharmacovigilance operations or regulatory leadership roles.
How to Apply
Visit our job portal and search for Pharmacovigilance Manager.
View the full job criteria by opening the link.
Complete the online application with the requested personal and professional information.
Upload your updated resume and any other documents.
Review your application and submit it.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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Hiring Trends
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