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Senior Patient Safety Expert
2 semanas atrás
The Patient Safety Specialist plays a vital role in ensuring robust, compliant, and consistent safety and risk management across all territories. This position supports the execution of pharmacovigilance activities in accordance with local regulatory requirements and BMS procedures.
Main Responsibilities- Risk Management: Contribute to the development and maintenance of Risk Management Plans.
- Safety Information: Provide safety information to internal and external stakeholders.
- PV Audit: Support PV audit and inspection readiness activities.
- Reporting: Plan, process, and report Aggregate Safety Reports to Health Authorities and Ethics Committees (as required).
- PV Awareness: Maintain PV awareness and deliver training programs.
- Implementation: Implement Pharmacovigilance Agreements.
- Audit Cases: Collect, follow-up, and forward spontaneous, literature, solicited, and post-marketing adverse event cases.
- Individual Case Reports: Submit individual case safety reports to local Health Authorities and Ethics Committees (as required).
- Education: University degree in Life Sciences or Nursing qualification.
- Experience: 2-3 years of experience in the pharmaceutical industry or a medical environment, ideally with exposure to PV or medical/scientific information services.
- Skills: Strong organizational, facilitation, and interpersonal skills.
- Communication: Excellent verbal and written communication skills.
- Problem-Solving: Ability to compile and present safety information clearly and concisely.
- Regulations: Understanding of local, regional, and international PV regulations.
- Familiarity: Familiarity with safety databases and internal PV systems.
- Workload: Ability to manage multiple tasks, prioritize effectively, and meet deadlines.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. The Company recommends that all employees be fully vaccinated for Covid-19 and keep up to date with boosters.
Work EnvironmentMinimal travel required. Occasional trips may include visits to BMS sites, Health Authorities, or attendance at professional meetings and seminars.