Safety Scientist, Expedited Safety Reporting

2-4 years

Not Disclosed

Hyderabad

Openings: 10 Posted: June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: ESR Scientist

Location: Global (Remote)

About Bristol Myers Squibb

Join Bristol Myers Squibb (BMS) where each day brings uniquely interesting work across every department, from optimizing production lines to pioneering breakthroughs in cell therapy. Our mission is to transform the lives of patients worldwide while fostering career growth and diversity among our high-achieving teams.

Working with Us

At BMS, we value balance and flexibility, offering competitive benefits and programs that support personal and professional goals. Explore more at BMS Careers.

Functional Area Description

The Worldwide Patient Safety (WWPS) group ensures the safety of our medicines through pharmacovigilance and pharmaco-epidemiology, overseeing safety monitoring, reporting, benefit-risk assessment, and compliance with global regulations.

Position Summary / Objective

The ESR Scientist collaborates with the Vendor SUSAR Support Team and Medical Review Safety Physicians (MRSP) to identify and report Expedited Safety Reports (ESRs) within global regulatory timelines.

Position Responsibilities

Narrative Preparation: Create accurate, integrated, and timely narrative summaries for expedited safety reports.
Safety Evaluation: Evaluate serious adverse event reports from diverse sources including clinical trials, spontaneous reports, and scientific literature.
Technical Support: Provide technical support to WWPS MRSP, interpreting and reviewing source documents as necessary.
Collaboration: Collaborate with investigators to gather additional information and prepare queries to support report accuracy.
Data Utilization: Utilize BMS safety and clinical databases to compile contextual summaries for expedited safety reports.
Process Coordination: Manage all aspects of report preparation, evaluation, review, and submission.
Quality Compliance: Adhere to WWPS and R&D SOPs, drug safety coding conventions, and contribute to process improvements.
Team Leadership: Support and lead teams involved in developing or revising WWPS SOPs and processes.

Requirements

Education: BSc/MSc Nursing; B.Pharm/M.Pharm/Pharm.D/BDS/BPT/MPT or Healthcare Degree preferred.
Experience: Minimum 4 years in pharmaceutical/healthcare or clinical development, with 2-3 years in Drug Safety in the pharmaceutical industry.
Skills: Strong medical writing skills for producing concise, accurate expedited reports. Proficiency in using drug safety databases.
Competencies: Ability to work effectively in teams, prioritize tasks, and adapt to changing priorities. Strong analytical thinking and familiarity with global Health Authority Regulations.
Attributes: Project planning skills with a focus on maintaining patient safety and regulatory compliance.

Workplace Culture and Benefits

Emphasis on work-life balance with competitive benefits and resources.
Commitment to diversity and inclusion in clinical trials and workforce.
Opportunities for professional development and global collaboration.

Application

If you are passionate about patient safety, experienced in drug safety reporting, and thrive in a collaborative, diverse environment, we encourage you to apply. Join Bristol Myers Squibb and contribute to our mission of transforming patients' lives through science.

For more details, visit BMS Careers.

This structured format presents the ESR Scientist role clearly, emphasizing responsibilities, requirements, and BMS's commitment to employee well-being and professional growth.

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