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

At Bristol Myers Squibb (BMS), we are committed to transformative work that impacts patients' lives worldwide. Our diverse teams drive innovation and uphold the highest standards in pharmaceuticals, ensuring compliance with global regulatory requirements while fostering a culture of growth and diversity.

Functional Area Description

The Worldwide Patient Safety (WWPS) group oversees pharmacovigilance and pharmaco-epidemiology deliverables, ensuring the safety and efficacy of our medicines through rigorous monitoring, reporting, and compliance with global regulations.

Position Summary

As an ESR Scientist, you will collaborate closely with the Vendor SUSAR Support Team and Medical Review Safety Physicians (MRSP) to identify and report Expedited Safety Reports (ESRs) within regulatory timelines worldwide. Your role is crucial in ensuring the accuracy and compliance of safety information.

Responsibilities

Narrative Preparation: Produce high-quality narrative summaries for expedited safety reports, ensuring accuracy and adherence to regulatory timelines.
Safety Evaluation: Evaluate serious adverse event reports from various sources including spontaneous reports, clinical trials, and scientific literature.
Technical Support: Provide technical support to WWPS Medical Review Safety Physicians, reviewing and interpreting source documents as needed.
Data Utilization: Utilize BMS safety and clinical databases to prepare contextual summaries for expedited safety reports.
Coordination: Coordinate all activities related to the preparation, evaluation, review, and submission of expedited safety reports.
Quality Compliance: Follow WWPS and R&D SOPs, ensure compliance with drug safety coding conventions, and contribute to continuous improvement initiatives.
Collaboration: Work with internal departments, drug development partners, and vendors to review documents, ensure data accuracy, and maintain regulatory compliance.

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 setting, with at least 2-3 years in Drug Safety specifically within the pharmaceutical industry.
Skills: Proficient in medical writing for expedited reports, experience with drug safety databases, and strong analytical skills.
Competencies: Ability to work effectively in teams, lead initiatives, prioritize tasks, and adapt to changing priorities. Understanding of global Health Authority Regulations and their application in drug safety.

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 aligns the job description clearly with responsibilities, requirements, and company culture, tailored for potential candidates interested in joining Bristol Myers Squibb as an ESR Scientist

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