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Bristol Myers Squibb
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Specialist, International Patient Safety

Specialist, International Patient Safety

Bristol Myers Squibb

2 - 6 years

7 - 11 Lacs

hyderabad

Posted:10 hours ago| Platform:

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Skills Required

medical writing patient safety data management ich-gcp guidelines pv drug safety clinical data management facilitation pharmacovigilance psur written communication case processing clinical research argus meddra clinical trials communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Contribute to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures.
Safety mailbox and communications management.
Support Aggregate Report related activities.
Maintenance of PV Awareness and other related Training content.
Implementation of Pharmacovigilance Agreements.
Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees.
Safety Data Quality activities e. g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities.
Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets.
Oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators.
PV activity planning and tracking e. g. signal communications to Health Authorities.
Collaborate and support cross-functional teams to ensure effective conduct of PV activities.
PV Audit and Inspection support (including preparation, conduct and follow-up actions. )

The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required.

Reporting Relationship

Functional and Managerial reporting lines into IPS.

Qualifications / Experience

Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team.
Strong interpersonal, verbal and written communication skills, ideally including the ability to communicate effectively across geographies and cultures, both live interactions and virtually.
Able to research, compile and provide (safety) information in a clear, concise manner.
An ability to understand local, regional and any other relevant legislation regarding PV (e. g. ICH, CIOMS).
Demonstrated ability to review (safety) information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines.
Utilizes effective problem-solving approaches to address (PV) issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes / guidelines / regulations.

Operational Skills:

Technical Proficiency: Basic use of standard operational software and tools for automation
Process Management: Understanding of processes and ability to evaluate and suggest digital improvements.
Problem-Solving: Addresses straightforward problems with simple digital solutions.
Analytical Skills:

Data Management: Processes and records data and information in structured computer readable formats
Critical Thinking: Identifies flaws and inconsistencies in data or business processes by considering the system wide impact.
Data Analysis: Can perform basic data gathering and reporting using standard tools.

Strategic Skills:

Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies.
Decision-Making: Uses data summaries to support decisions based on clearly defined options and guidelines
Change Management: Supports digital change initiatives and communicates their immediate benefits.

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