Director, Medical Safety Assessment Physician, Immunology

3+ years

Not Disclosed

Hyderabad

10 Dec. 13, 2024

Job Description

Job Type: Full Time Education: MD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

At Bristol Myers Squibb (BMS), we do work that challenges, inspires, and transforms lives. From groundbreaking cell therapy advancements to optimizing production processes, every role contributes to life-changing outcomes for patients. Our workplace fosters professional growth through unique opportunities alongside high-achieving, diverse teams. This is where careers thrive, far beyond what you may have imagined.

We also prioritize balance and flexibility in the workplace, offering a variety of competitive benefits and resources to support both personal and professional goals. Learn more: careers.bms.com/working-with-us.

Functional Area Overview

The Worldwide Patient Safety (WWPS) group ensures the safety of BMS medicines through pharmacovigilance and pharmacoepidemiology. Core deliverables include single-case and aggregate safety monitoring, benefit-risk assessments, risk management strategies, post-marketing commitments, and global regulatory compliance.

Position Summary

In this role, you will:

Lead safety activities and benefit-risk strategies for BMS compounds in the Immunology Therapeutic Area (TA).
Chair product Safety Management Teams (SMTs).
Develop and oversee strategies for signal evaluation and document outcomes.
Act as the Safety Subject Matter Expert for regulatory product labeling and collaborate on cross-functional labeling teams.
Support process improvements in Pharmacovigilance (PV) procedures and ensure alignment with global regulatory requirements.
Represent WWPS at health authority (HA) and Data Monitoring Committee (DMC) meetings.
Promote teamwork and serve as a mentor and change agent for colleagues.

Position Responsibilities

General Product Support

Lead safety and benefit-risk strategies for assigned compounds, chairing SMTs.
Prepare and review aggregate safety documents (e.g., DSURs, PBRERs), clinical trial documentation, and regulatory filings.
Evaluate and manage safety signals from diverse data sources and document findings.
Oversee safety labeling and provide expertise for regulatory product labeling processes.

Clinical Development

Serve as the global safety lead for development-stage compounds.
Lead the creation and execution of benefit-risk management strategies.
Provide safety input to clinical trial documents and regulatory submissions.
Contribute to pre-submission preparations and strategy discussions with HAs and advisory committees.

Post-Marketing Support

Act as the safety lead for marketed products, overseeing global safety activities and submissions.
Manage risk strategies, safety signal evaluations, and safety study guidance.
Ensure safety labeling reflects the post-marketing safety profile.

Department Activities

Lead process improvement initiatives and ensure compliance with regulatory expectations.
Assist in issue and crisis management while fostering a collaborative team environment.

Cross-Functional Engagement

Contribute to strategic safety differentiation plans and internal training efforts.
Collaborate with teams across Legal, Marketing, Operations, and Manufacturing.
Develop communications of safety data and analysis for both internal and external stakeholders.

Qualifications

Educational Requirements

MD or equivalent required, with a preference for postgraduate qualifications in internal medicine, immunology, or related fields.

Experience Requirements

3+ years in PV or a related field (e.g., medical, clinical, or regulatory).
Relevant experience in clinical research or practice is also considered valuable.

Key Competencies

Deep understanding of the drug development lifecycle and PV processes.
Analytical reasoning skills for assessing and mitigating safety concerns.
Proficiency in managing multiple projects with exceptional attention to detail.
Strong interpersonal and communication skills, suited to a complex matrix environment.

Our Commitment to You

BMS is committed to fostering an inclusive workplace where employees of all abilities and backgrounds thrive. We encourage candidates with diverse experiences to apply, even if their qualifications don't perfectly align with the role.

BMS supports employee well-being through recommended COVID-19 vaccinations, flexible working options, and accommodations for disabilities. Learn more about our Equal Employment Opportunity policies: careers.bms.com/eeo-accessibility.

Transform your career, transform lives. Explore opportunities that redefine what's possible at BMS.

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