Remote Medical Director, Pharmacovigilance

Kids for the Future; Waltham (MA); On-site; USD 265,000 - 305,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision coverage

401(k) company match

Employee Stock Purchase plan

Generous vacation and holidays

Job summary

Viridian Therapeutics, Inc. seeks a Medical Director of Pharmacovigilance to lead safety activities for assigned products, including signal detection, safety assessment, and regulatory reporting.

The role partners with clinical development, regulatory, and quality teams to ensure compliant safety oversight across programs, including Phase 3 trials. The position is fully remote with some travel to headquarters as needed.

Qualifications

• Medical Doctor Degree required.
• 7+ years of pharmacovigilance/related experience.
• Experience with aggregate safety reports (DSURs, PSURs/PBRERs, IND Annual Reports).

Responsibilities

• Provide medical leadership for pharmacovigilance activities for assigned products.
• Lead or co-lead Safety Management Team activities for programs.
• Review serious adverse events, SUSARs, and safety data for regulatory reporting.
• Oversee outsourced pharmacovigilance activities and vendor performance.
• Develop safety monitoring plans and data review plans for clinical studies.
• Contribute to data review and interpretation to support program decisions.
• Prepare safety content for regulatory submissions and safety reports.
• Coordinate aggregate safety report planning and execution.
• Partner with multiple stakeholders to identify and mitigate safety risks.
• Support risk minimization measures and safety governance decisions.
• Coordinate health authority responses and safety inquiries.
• Provide medical input to SOPs and process improvements.
• Mentor PV team members and cross-functional colleagues.
• Perform other duties as assigned.

Skills

Medical Doctor Degree

7+ years pharmacovigilance

Aggregate safety reporting

FDA/EMA/ICH guidelines

GVP / GCP guidelines

Argus / MedDRA / WHO Drug Dictionary

CRO/vendor oversight

SOPs and safety processes

Excellent communication

10-15% travel

Drug development lifecycle

Education

Medical Doctor Degree

Tools

Argus

MedDRA

WHO Drug Dictionary

Job description

Viridian Therapeutics, Inc. seeks a Medical Director of Pharmacovigilance to lead safety activities for assigned products, including signal detection, safety assessment, and regulatory reporting.

The role partners with clinical development, regulatory, and quality teams to ensure compliant safety oversight across programs, including Phase 3 trials. The position is fully remote with some travel to headquarters as needed.