Senior Medical Safety Lead — PV & Risk Strategy (Hybrid)

Thepharmadaily LLP; Bristol; Hybrid; GBP 85,000 - 110,000; Full time

Job summary

A global biopharmaceutical company is seeking an experienced Associate Director, Medical Safety Assessment Physician to lead medical safety activities and pharmacovigilance strategies. This role involves overseeing clinical development and regulatory submissions, ensuring patient safety, and driving risk management strategies. The ideal candidate has an MD, at least 3 years of experience in pharmacovigilance, and strong communication skills. The position offers a competitive salary and flexible work arrangements.

Benefits

Competitive salary

Health benefits

Professional development opportunities

Flexible work arrangements

Qualifications

• Minimum 3+ years of pharmacovigilance or relevant pharmaceutical/biomedical experience preferred.
• Deep understanding of drug development lifecycle and pharmacovigilance regulations.
• Expertise in signal detection, risk management, and benefit-risk evaluation.

Responsibilities

• Lead safety assessment and benefit-risk strategies for assigned BMS compounds.
• Provide safety input for regulatory submissions, product labeling, and risk management plans.
• Drive process improvement projects and implement PV methodology.

Skills

Causality Assessment

Clinical SAS Programming

Communication Skills

CPC Certified

GCP guidelines

ICD-10 CM Codes

CPT-Codes

HCPCS Codes

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

Education

MD or equivalent

Postgraduate qualification in Internal Medicine, Immunology, Oncology

Job description

A global biopharmaceutical company is seeking an experienced Associate Director, Medical Safety Assessment Physician to lead medical safety activities and pharmacovigilance strategies. This role involves overseeing clinical development and regulatory submissions, ensuring patient safety, and driving risk management strategies. The ideal candidate has an MD, at least 3 years of experience in pharmacovigilance, and strong communication skills. The position offers a competitive salary and flexible work arrangements.