Medical Safety Review Lead

4 weeks ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Description

Job Summary

The Associate Director, Medical Safety Review will provide high-quality medical review of Individual Case Safety Reports (ICSRs), including determination of regulatory reportability of clinical trial cases and certain post-marketing reports. The role supports signal detection and risk management-related activities.

Key Responsibilities

  • Provides high-quality medical assessment of ICSRs with particular attention to critical cases (SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [pDILI], pregnancy, any critical events).
  • Provides seriousness, causality, and expectedness assessment and determines regulatory reportability of ICSRs for assigned products.
  • Serves as a medical expert in signal detection and risk management-related activities.
  • Ensures complete and timely reporting of ICSRs to regulatory authorities globally for products of responsibility.
  • Collaborates with Quality, Standards, and Training teams to ensure consistency of work practices and SOPs.
  • Partners with WWPS personnel from other functions (Case Management, PV Scientists, Expedited Safety Reporting [ESR] Safety Scientists, and Medical Safety Assessment Physicians [MSAP]) in evaluating the safety profile of BMS compounds of responsibility.

Requirements

  • MD or Equivalent.
  • Board certification and medical specialty preferred.
  • Minimum 2-4 years in clinical practice or relevant setting.
  • Minimum 1-3 years of pharmaceutical industry experience.

Competencies

  • Knowledgeable and skilled in medicine and pharmaceutical product safety.
  • Experience applying medical knowledge to the interpretation of individual case review; experience with reporting of individual adverse events.
  • Previous experience in the safety field and/or pharmaceutical industry preferred.
  • Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers.

About Bristol Myers Squibb

Bristol Myers Squibb is committed to transforming patients' lives through science. With a single vision as inspiring as 'Transforming patients' lives through scienceTM ', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.



  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    At Bristol Myers Squibb, we are committed to transforming patients' lives through science.We are currently seeking an Associate Director, Medical Safety Review to join our team in this exciting opportunity!About the RoleThis is a site-essential role requiring 100% of shifts onsite at your assigned facility. As a member of our Worldwide Patient Safety group,...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryWe are seeking an experienced Associate Director, Medical Safety Review to join our team at Bristol Myers Squibb. This role will be responsible for providing high-quality medical review of Individual Case Safety Reports (ICSRs) and supporting signal detection and risk management activities.Key ResponsibilitiesProvide medical assessment of ICSRs...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Join a team that shares your passion for transforming patients' lives through science. We're seeking a talented Director of Medical Safety Oversight to lead our medical review efforts and ensure the safety of our medicines.About the RoleThis is an exciting opportunity to leverage your expertise in medicine and pharmaceutical product safety to drive...


  • Hyderabad, Telangana, India Lifelancer Full time

    Unlock Your Potential in LifelancerAre you passionate about ensuring the highest quality standards in medical review operations? Do you thrive in a dynamic environment where precision and attention to detail are paramount? Look no further! We invite highly skilled professionals to join our team as Lead Quality Assurance Specialist for Medical Review...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job DescriptionWe are seeking a skilled and detail-oriented professional to join our team as a Safety Data Reconciliation Lead. In this critical role, you will be responsible for ensuring the quality and accuracy of adverse event reports, as well as navigating the intricacies of our drug safety databases to process adverse event reports.Key...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Unlock Your Potential as a Lead Medical Coding SpecialistWe are seeking a highly skilled and experienced Lead Medical Coding Specialist to join our team at Bristol Myers Squibb. As a key member of our Global Patient Safety group, you will play a crucial role in ensuring the accurate and efficient coding of adverse events in safety or clinical...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job DetailsThis is a Medical Data Safety Specialist role where you will be part of the Pharmacological Department. Your key responsibility will be to report adverse effects and side effects, in accordance with current Dutch and European legislation for pharmacology.You may also train colleagues in departments such as marketing and sales, medical and clinical...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    About the RoleThe Worldwide Patient Safety group at Bristol Myers Squibb is responsible for ensuring the safety of our medicines. As a Safety Specialist, Regulatory Compliance, you will contribute to pharmacovigilance and pharmaco-epidemiology deliverables, including single case and aggregate safety monitoring, safety reporting, and risk management...


  • Hyderabad, Telangana, India Parexel Full time

    Job Purpose:Provide medical review, analysis, and guidance during the drug safety reporting cycle.Assess the clinical relevance of medical data and provide medical advice to team members.Maintain a good working knowledge of drug safety regulations and guidelines.Responsibilities:Perform medical review of cases according to SOPs and liaise with clients.Assess...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryThe Expedited Safety Reporting (ESR) Scientist is responsible for ensuring the timely and accurate reporting of safety information to regulatory agencies worldwide. This role requires strong analytical and communication skills, as well as the ability to work effectively in a team environment.Key ResponsibilitiesPrepare high-quality narrative...


  • Hyderabad, Telangana, India Parexel Full time

    About the Role:We are seeking a skilled Medical Review Specialist - Pharmacovigilance to join our team at Parexel.Responsibilities:Perform medical review of cases according to client Standard Operating Procedures (SOPs) and liaise with the client, as required.Write Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assess company...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryWe are seeking an Associate Safety Scientist to support the Expedited Safety Reporting team at Bristol Myers Squibb. As an Associate Safety Scientist, you will play a key role in ensuring the quality and integrity of safety data, working closely with safety scientists and medical review safety physicians to expedite the processing of SUSAR...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    DescriptionThe Worldwide Patient Safety group at Bristol Myers Squibb is responsible for ensuring the safety of our medicines. This includes all pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and...


  • Hyderabad, Telangana, India ARVIK MEDICAL SYSTEMS LLP Full time

    Medical Sales Position at ARVIK MEDICAL SYSTEMS LLPWe are seeking a skilled Medical Sales Representative to join our team. The ideal candidate will have a strong understanding of the pharmaceutical industry and excellent communication skills.Key Responsibilities:Selling company medications to doctors, pharmacists, and other healthcare...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryThe Expedited Safety Reporting (ESR) Scientist is a key member of the Worldwide Patient Safety (WPS) team at Bristol Myers Squibb (BMS). This role is responsible for ensuring the accuracy and quality of safety information in ESRs submitted to regulatory agencies worldwide.Key ResponsibilitiesPrepares high-quality narrative summaries for expedited...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    About the JobWe are seeking a highly skilled Clinical Data Quality Specialist to join our Patient Safety team at Bristol Myers Squibb. This is an exciting opportunity for individuals who are passionate about ensuring the quality and integrity of clinical data.Job SummaryThe Clinical Data Quality Specialist will be responsible for conducting in-line quality...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryWe are seeking a talented Senior Medical Quality Specialist to join our team at Bristol Myers Squibb. In this role, you will be responsible for conducting in-line quality reviews of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements and company conventions.Key...


  • Hyderabad, Telangana, India ARVIK MEDICAL SYSTEMS LLP Full time

    Key Responsibilities:Selling company medications to doctors, pharmacists, and other healthcare professionals.Scheduling appointments with healthcare professionals to promote company medications.Developing an in-depth understanding of company medications.Building and maintaining good business relationships with customers to encourage repeat...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryThe ideal candidate will possess a strong background in pharmacovigilance and safety data processing, with a focus on adverse event reconciliation. In this role, the Safety Data Analyst, Reconciliation Specialist will be responsible for reviewing and reconciling adverse event data in the Worldwide Patient Safety database and clinical trial...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummaryWe are seeking a highly skilled Medical Coding Manager to join our Worldwide Patient Safety team. As a key member of our global team, you will be responsible for delivering accurate and consistent medical coding within established timelines and in compliance with all processes, guidelines, and conventions.Key ResponsibilitiesDeliver high-quality...