Manager, International Patient Safety

Bristol Myers Squibb

2 - 3 years

8 - 12 Lacs

hyderabad

Posted:2 days ago| Platform:

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Skills Required

capa data analysis construction safety safety engineering facilitation occupational health industrial safety safety management safety training written communication safety safety audit hse safety officer activities communication skills inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

Oversee, mentor and guide Senior Specialists in IPS, to ensure high-quality safety deliverables across the team.
Contribute to/Lead 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/Lead Aggregate Report related activities.
Lead the creation/update 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.
Lead the 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, under minimal supervision.
Strong interpersonal, verbal and written communication skills, 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 understanding of 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: Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows.
Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods.
Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.
Analytical Skills:

Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data.
Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments.
Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality.
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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