Specialist, International Patient Safety

0 - 4 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a member of the International Patient Safety (IPS) team at Bristol Myers Squibb, you will play a crucial role in ensuring robust, compliant, and consistent safety and risk management across all territories where BMS operates. Your responsibilities will include: - Contributing to the creation and maintenance of risk management plans and providing support for the effective implementation of Additional Risk Minimisation measures. - Managing safety mailbox and communications effectively. - Supporting Aggregate Report related activities. - Maintaining PV Awareness and other related Training content. - Implementing Pharmacovigilance Agreements. - Handling Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. - Conducting Safety Data Quality activities such as PV System Master File maintenance, deviations/CAPA management, and other quality control and oversight activities. - Compiling PV-related documentation for third parties responsible for Distributor/Local Representative Markets. - Overseeing the performance of Distributor/Local Representative Market third parties, in line with PV Agreement key performance indicators. - Planning and tracking PV activities including signal communications to Health Authorities. - Collaborating and supporting cross-functional teams to ensure effective conduct of PV activities. - Providing PV Audit and Inspection support, including preparation, conduct, and follow-up actions. Your qualifications and experience should include: - Ability to provide quality work using strong organizational, facilitation, and interpersonal skills in a cross-functional team. - Strong interpersonal, verbal, and written communication skills, with the ability to communicate effectively across geographies and cultures. - Understanding of local, regional, and relevant legislation regarding PV. - Demonstrated ability to review safety information with attention to detail and accuracy while managing multiple tasks and meeting strict deadlines. - Basic use of standard operational software and tools for automation. - Understanding processes and ability to evaluate and suggest digital improvements. - Addressing straightforward problems with simple digital solutions. - Processes and records data and information in structured computer-readable formats. - Identifying flaws and inconsistencies in data or business processes and supporting decisions based on clearly defined options and guidelines. You should be a university graduate with a degree in life science or a nursing qualification, with strong written and spoken English communication skills. Minimal travel may be required for this position. If this role intrigues you, even if it doesn't perfectly align with your resume, we encourage you to apply. Bristol Myers Squibb offers a supportive work environment that promotes global participation in clinical trials and values passion, innovation, urgency, accountability, inclusion, and integrity. BMS is committed to ensuring equal employment opportunities for all individuals, including those with disabilities. The company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. Data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.,

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Bristol Myers Squibb logo
Bristol Myers Squibb

Pharmaceutical Manufacturing

Lawrence Township NJ

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