Lead Drug Safety Physician

Thorough Group; Minnesota; On-site; USD 250,000 - 360,000; Full time

Job summary

Thorough Group, a growing biopharmaceutical company, seeks a Lead Drug Safety Physician to provide medical leadership across its clinical and commercial portfolio.

The role focuses on benefit-risk assessment, signal detection, safety governance, and regulatory strategy, with responsibilities spanning DSURs/PSURs, risk management, and collaboration with cross-functional teams.

Qualifications

• MD or equivalent medical degree required.
• Board certification in a relevant medical specialty preferred.
• Approximately 8+ years of Pharmacovigilance/Drug Safety experience in biotechnology/pharmaceutical drug development.
• Leadership experience within a Drug Safety/PV organization.
• Experience leading benefit-risk assessments and complex safety signal evaluations.
• Experience authoring/reviewing DSURs, PSURs/PBRERs, RMPs, and other aggregate safety reports.
• Experience supporting Phase 2 and Phase 3 clinical development programs.
• Experience interacting with regulatory authorities (FDA/EMA).
• Familiarity with Argus or similar global safety databases and MedDRA.

Responsibilities

• Provide medical leadership and oversight for benefit-risk profiles of investigational and marketed products.
• Lead proactive signal detection, evaluation, validation, and risk-management activities.
• Chair or lead Safety Review Committees and other safety governance forums.
• Drive benefit-risk decisions influencing clinical protocols, development strategy, labeling, and regulatory submissions.
• Oversee preparation and medical review of aggregate safety reports (DSURs, PSURs/PBRERs, RMPs).
• Provide medical oversight of serious and medically significant adverse events.
• Collaborate with Clinical Development to integrate safety endpoints and risk-mitigation in protocols.
• Engage with Regulatory Affairs, Medical Affairs, Biostatistics, and PV Operations.
• Represent Drug Safety with global health authorities and external experts.
• Support inspection-readiness and ensure compliance with global regulatory requirements.
• Mentor Drug Safety physicians and scientists as the organization grows.

Skills

Leadership

Pharmacovigilance

Signal detection

Regulatory strategy

Safety governance

Medical leadership

DSURs PSURs

Team mentoring

FDA EMA interactions

Education

MD or equivalent medical degree

Board certification

Tools

Argus

MedDRA

Job description

Thorough Group is partnering with an established, growing biopharmaceutical company to identify an experienced Lead Drug Safety Physician to provide medical leadership across its expanding clinical and commercial portfolio.

This is a highly visible leadership opportunity for an experienced Drug Safety physician who will have significant responsibility for benefit-risk assessment, signal detection and management, aggregate reporting, regulatory strategy, and safety governance.

Working closely with senior leadership and cross-functional partners, this individual will help shape the safety strategy for both investigational and marketed therapies while supporting multiple mid- and late-stage clinical development programs.

Key Responsibilities

• Provide medical leadership and oversight for the benefit-risk profiles of investigational and marketed products
• Lead proactive signal detection, evaluation, validation, and risk-management activities
• Chair and/or provide medical leadership to Safety Review Committees and other safety governance forums
• Drive benefit-risk decisions that may inform clinical protocols, development strategy, labeling, regulatory submissions, and risk-management activities
• Lead the preparation, medical review, and submission of aggregate safety reports, including DSURs, PSURs/PBRERs, and Risk Management Plans
• Provide medical oversight and assessment of serious and medically significant adverse events
• Partner with Clinical Development to incorporate appropriate safety endpoints, monitoring strategies, and risk-mitigation measures into clinical protocols
• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, and PV Operations
• Represent Drug Safety/PV during interactions with global health authorities and external scientific experts
• Support inspection-readiness and ensure pharmacovigilance activities meet applicable global regulatory requirements
• Mentor and provide leadership to Drug Safety physicians and scientists as the organization continues to grow

Required Experience

• MD or equivalent medical degree
• Board certification in a relevant medical specialty preferred
• Approximately 8+ years of Pharmacovigilance/Drug Safety experience within biotechnology or pharmaceutical drug development
• Previous leadership experience within a Drug Safety/PV organization
• Demonstrated experience leading benefit-risk assessments and complex safety signal evaluations
• Strong experience authoring and/or medically reviewing DSURs, PSURs/PBRERs, RMPs, and other aggregate safety reports
• Experience supporting Phase 2 and Phase 3 clinical development programs
• Experience interacting with regulatory authorities, including the FDA and/or EMA
• Strong understanding of global pharmacovigilance regulations and applicable FDA, EMA, and ICH requirements
• Experience with Argus or comparable global safety databases and familiarity with MedDRA
• Ability to translate complex clinical and safety data into clear recommendations for senior leadership, development teams, and regulatory authorities

Preferred Background

Experience in one or more of the following areas would be particularly valuable:

• Oncology
• Endocrinology
• Metabolic disease
• Late-stage clinical development
• Commercial/marketed product safety
• Regulatory submissions and labeling
• Global pharmacovigilance and risk-management activities
• Building or expanding Drug Safety/PV capabilities within a growing biotech organization

Why This Opportunity?

This individual will join a science-driven biopharmaceutical company with a growing pipeline and multiple advanced clinical programs.

Unlike a highly siloed Drug Safety position, this role provides an opportunity to influence both strategy and execution. The Lead Drug Safety Physician will work closely with senior leadership and have a meaningful voice in benefit-risk decisions, clinical development strategy, regulatory interactions, and the continued evolution of the company’s Pharmacovigilance organization.

This is an excellent opportunity for a physician who enjoys working in a collaborative, entrepreneurial environment and wants their medical judgment to have a direct impact on development programs and ultimately patients.