Functional Area Description The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines : The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Position Summary / Objective Is expected to support the Local Market (LM) Patient Safety team perform the core pharmacovigilance (PV) / patient safety activities listed below in line with local regulatory and relevant legal requirements, and BMS procedures.
Under the direct or indirect supervision of the Head of Patient Safety of the Country / Patient Safety Hub / Cluster, the Specialist PS is responsible for performing / providing assistance in the performance of some of the required local market core PV activities and other activities to support the daily functioning of the LM Patient Safety team.
Position Responsibilities Risk management plans Provision of safety information Implementation of PV Audit and Inspection Readiness Planning, processing and reporting of Aggregate Reports to HA and EC (as required) Maintenance of PV Awareness and Training Implementation of Pharmacovigilance Agreements Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases (as applicable) Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required) Local Market Safety Data Quality Note : for greater detail of the specific responsibilities and duties refer to the International Patient Safety Core Activities of the Local Market Patient Safety Personnel.
Experience Requirements Administrative experience in a professional, multinational, business environment, including coordination of meetings, managing calendars, organising travel and organizing documentation.
Key Competency Requirements Works well in a team environment, excellent interpersonal skills and demonstrates a 'can do' approach.
Provides effective support to management through the development of organizational and / or administrative processes for efficient office management.
Develops excellent working relationships internally and externally. Deals will all levels of management. Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups and relevant local departments e.
g. Regulatory, Medical and Clinical Teams and how these teams interact. Uses these formal and informal networks to assist in goal achievement.
Is able to prioritize multiple tasks and efficiently allocate time to different aspects of work in order to meet deadlines.
Seeks necessary support from PV supervisor to effectively solve issues, utilizing effective problem-solving approaches. Demonstrates good initiative and follow-up, with accuracy and attention to detail.
Possesses problem solving as well as excellent communication skills, both verbal and written. Exhibits professionalism and strong business ethics by maintaining confidentiality where appropriate, exhibiting candor and honesty with co-workers, and respecting Company policies and privileges.
willing to enhance current skills to maximize proficiency. Travel Required : None (Disclaimer : The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned) Around the world, we are passionate about making an impact on the lives of patients with serious diseases.
Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.