At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients lives through science.
The Role
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.
We are now recruiting the Manager, Patient Safety, Saudi Arabia, based in Riyah who will be responsible for performing some or all of the required pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and BMS procedures, under the supervision of the LMPS Lead (or designee).
Key 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
• As applicable, collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
• 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 and Re q uirements:
• Bachelor degree in Pharmacy ( Holding Valid Saudi Health specialties license)
• 2-3 years experience of working in the pharmaceutical industry or a medical environment. Ideally having provided PV or medical/scientific information service in a health care environment.
• Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within Worldwide Patient Safety and externally.
• Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups. Has a good understanding of relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact (or similar experience in another company).
• Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local /regional team and Worldwide Patient Safety HQ as appropriate.
• An understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as BMS corporate and local systems (e.g. Global Safety Database, local data bases) and procedures, in order to fulfill regulatory requirements for pharmacovigilance.
• Maintains an awareness of the safety profile and any emerging pharmacovigilance/patient safety issues with BMS products (marketed or investigational )in the local affiliate and with support able to represent the local Patient Safety function on cross functional teams, providing input on drug safety issues.
• Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work in order to meet strict deadlines. Utilizes effective problem-solving approaches to solve PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations.
• Minimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars.
• Fluent in Arabic and English, both speaking and writing.
What s important to us
Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:
Passion : Our dedication to learning and excellence helps us to deliver exceptional results.
Innovation : We pursue disruptive and bold solutions for patients.
Urgency : We move together with speed and quality because patients are waiting.
Accountability : We all own BMS success and strive to be transparent and deliver on our commitments.
Integrity: We demonstrate ethics, integrity, and quality in everything we do for patients, customers, and colleagues.
Inclusion : We embrace diversity and foster an environment where we can all work together at our full potential.
We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve
#LI-Onsite
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.
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