Safety Scientist, Expedited Safety Reporting

2-4 years

Not Disclosed

Hyderabad

10 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 Description

Working with Us

Challenging. Meaningful. Life-changing. These aren’t words usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing production lines to pioneering breakthroughs in cell therapy, our work transforms patients' lives and the careers of those who do it. You’ll have the opportunity to grow and thrive through opportunities that are uncommon in scale and scope, alongside high-achieving, diverse teams. Take your career farther than you ever thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more at careers.bms.com/working-with-us.

Division

Research and Development / Global Regulatory & Safety Sciences / Worldwide Patient Safety / Medical Safety Review / Expedited Safety Reporting

Functional Area Description

The Worldwide Patient Safety group ensures the safety of our medicines through pharmacovigilance and pharmaco-epidemiology deliverables. This includes single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, execution of post-marketing commitments, and ensuring compliance with global regulatory requirements.

Position Summary / Objective

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

Position Responsibilities

Prepare high-quality narrative summaries for expedited safety reports, ensuring all safety information is accurate, integrated, and current, and submitted within regulatory timelines.
Participate in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports, and scientific literature.
Provide technical support to WWPS Medical Review Safety Physicians (MRSP), including reviewing and interpreting source documents.
Identify additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information.
Utilize BMS safety and clinical databases to prepare contextual summaries for expedited safety reports.
Coordinate activities around the preparation, evaluation, review, and submission of expedited safety reports.
Review and comment on documents and line listings from WWPS, other BMS departments, and other drug development/marketing partners and contractors.
Follow BMS WWPS and R&D SOPs, drug safety coding conventions, and work aids.
Perform analysis of similar events for SUSAR reports, potential Drug-Induced Liver Injury (DILI), and events of special interest cases.
Serve as a resource for WWPS to provide SUSAR-related information; help develop and participate in and/or lead teams involved with developing or revising WWPS SOPs.
Work with WWPS vendors & partners providing oversight/guidance for the ESR/SUSAR process.

Disclaimer: The responsibilities listed above are a summary and other responsibilities may be assigned.

Degree Requirements

BSc/MSc in Nursing; B. Pharm/M.Pharm/Pharm.D/BDS/BPT/MPT or a healthcare degree preferred.

Experience Requirements

4 years of experience in a pharmaceutical/healthcare or clinical development setting, or 2-3 years of drug safety experience within the pharmaceutical industry.

Key Competency Requirements

Medical writing skills to produce accurate, concise, medically sound expedited reports.
Experience using a drug safety database to capture adverse events.
Experience in post-marketing safety or a clinical trial setting (e.g., CRO, pharmaceutical company, academic setting).
Experience working in teams, supporting other team members, and leading a team.
Strong prioritization skills to ensure consistency across WWPS processes, procedures, and best practices, and meeting regulatory requirements timely and with high quality.
Ability to make constructive recommendations for process improvements.
Ability to multi-task and adapt to changing business priorities.
Collaboration skills within multi-disciplinary teams on drug safety-related issues, including informing safety physicians and scientists on case-related issues.
Analytical thinking and database query skills to gather, review, summarize, and evaluate critical information timely.
Medical, scientific, and clinical knowledge in reviewing safety-related documents and incorporating key concepts to maintain patient safety.
Knowledge of global Health Authority Regulations and the ability to access and refer to them as needed.
Ability to support WWPS Vision and Mission through understanding the impact of daily work on all customers of the Expedited Safety Reporting team.
Project planning skills.

If a role intrigues you but doesn’t perfectly align with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a vision of “Transforming patients’ lives through science™,” every BMS employee plays a crucial role in work that goes beyond the ordinary. Our inclusive culture promotes diversity in clinical trials, while our values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential in each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure determining where an employee conducts their work:

Site-essential roles: 100% onsite.
Site-by-design roles: Eligible for a hybrid model with at least 50% onsite presence.
Field-based and remote-by-design roles: Travel to visit customers, patients, or business partners, and attend meetings as directed is essential.

Accessibility and Accommodations

BMS ensures that people with disabilities can excel through transparent recruitment, reasonable accommodations, and ongoing support. Applicants can request accommodations during the recruitment process. For accommodations, direct inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

Covid-19 Protocol

BMS cares about the well-being of our staff, customers, patients, and communities. We strongly recommend that all employees be fully vaccinated for Covid-19 and stay updated with boosters.