Pharmacovigilance Specialist at Bristol Myers Squibb

Descriere

Data : martie 31, 2022
Locație : Bucuresti

Candidatul Ideal

Degree Requirements
University degree (preferably life science) or nursing qualification.

Experience Requirements
Ideally, some experience of working in a medical environment or a reasoned desire to gain experience in PV.

Key Competency Requirements

Ability to deliver quality work using strong organizational, facilitation, and interpersonal skills in a cross-functional team locally. Understands relationships within GPVE & externally.
Develops a good understanding of the BMS organization, in particular, the Global and Regional Safety groups and relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact.
Possess good interpersonal, verbal, and written communication skills. Able to learn the skills required to research, compile and provide safety information in a clear concise manner to the local team.
Ability to develop a good 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) and procedures, in order to fulfil regulatory requirements for Pharmacovigilance.
Develops an awareness of the safety profile and any emerging pharmacovigilance/patient safety issues with BMS products (marketed or investigational) in the local affiliate.
Develops the ability to review safety information with attention to detail and accuracy in verification of source data and related safety documentation/records. Able to prioritize multiple tasks to meet deadlines, effectively solve PV issues and utilizing effective problem-solving approaches with guidance from supervisor.
Ability to comply with relevant internal and external processes/guidelines/regulations.

Descrierea jobului

Job Title
Specialist, Patient Safety

Division
Research and Development / Global Regulatory, Safety and Biometrics /
Worldwide Patient Safety / International Patient Safety

Functional Area Deion
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 be able to learn the required pharmacovigilance/patient safety activities listed below in line with local regulatory and relevant legal requirements and BMS procedures, under the supervision of the LMPS Lead (or designee).
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
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 Pharmacovigilance Core Activities of the Local Market PV Personnel.


Benefits:
– Regina Maria medical subion (under BMS conditions – with 20% employee contribution),
– meal vouchers – 20 Ron / day worked,
– the possibility to receive Easter / Christmas gift vouchers,
– settlement of public transport up to 150 RON / month,
– annual bonus, depending on the performance
– 21 days of rest leave/year
The working hours are 8 hours/day, with a 30-minute lunch break that is not included during working hours. The work schedule has a flexible structure, between 7.30 and 18.30.

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Locație

Bucuresti
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