Medical Director/Sr Medical Director, Drug Safety & Pharmacovigilance

7+ years

Not Disclosed

Remote

10 Oct. 22, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Medical Director/Sr. Medical Director, Drug Safety & Pharmacovigilance

Location: Fully Remote

Company Overview

At Viridian Therapeutics, we are dedicated to developing best-in-class medicines for individuals living with autoimmune and rare diseases. Our expertise in antibody discovery and engineering has led to a robust pipeline of innovative therapeutic candidates. We prioritize data-driven decisions, open communication, and a culture that empowers our team to grow both personally and professionally.

Position Overview

Reporting to the Vice President of Pharmacovigilance, the Medical Director/Sr. Medical Director of Drug Safety & Pharmacovigilance will lead core medical safety activities to support the monitoring and evaluation of the safety profile for assigned products. This role requires an experienced safety physician who can provide medical expertise while collaborating with stakeholders across clinical development, biostatistics, clinical operations, and medical affairs.

Responsibilities

Provide medical and scientific expertise in drug safety and pharmacovigilance, including worldwide signal detection, risk-benefit assessments, and safety evaluations.
Lead quarterly Safety Management Team meetings, analyzing clinical trial data, non-clinical data, literature reports, and competitive intelligence.
Assist in implementing clinical strategy for lead programs, focusing on mid to late-stage development and commercialization.
Design and implement safety strategies for clinical studies, including ongoing safety data review and response to safety issues.
Review clinical data from various sources to support program go/no-go decisions.
Coordinate safety outputs for signaling activities and ad hoc requests.
Contribute to the creation and revision of Investigator Brochures and Risk Safety Information documents.
Oversee Aggregate Report coordination, including scheduling and drafting safety portions.
Collaborate with clinical, medical, quality, and regulatory teams on safety and pharmacovigilance issues.
Review Serious Adverse Events (SAEs) and ensure timely analysis for health authority submissions.
Assist in developing and executing Medical Affairs strategies, including external stakeholder management and medical education.

Requirements

Medical Doctor (MD) degree required.
7+ years of experience in pharmacovigilance, including aggregate safety reports, signal management, and regulatory documentation.
Strong knowledge of FDA, EMA, and ICH guidelines related to safety reporting and clinical trials.
Familiarity with EU GVP, Good Clinical Practices (GCP), MedDRA, and WHO Drug Dictionary terminology.
Experience with safety databases, preferably ARGUS.
Knowledge of risk management activities and drug development processes.
Excellent organizational, verbal, and written communication skills.
Ability to thrive in a fast-paced environment and manage changing priorities.
Proficient in Microsoft Office Suite.
Approximately 10-15% travel may be required.

Compensation and Benefits

Competitive salary and stock options.
Comprehensive medical, dental, and vision coverage (100% premium paid for employees and eligible dependents).
Fertility and mental health programs.
Short- and long-term disability coverage.
401(k) Company Match with immediate vesting.
Generous vacation plan and paid company holiday shutdowns.
Employee Stock Purchase Plan.
Various health and wellness programs.

Equal Employment Opportunity

Viridian Therapeutics, Inc. is an equal opportunity employer and prohibits discrimination or harassment of any kind. We are committed to providing reasonable accommodations for individuals with disabilities during the application or interview process. Please contact us for assistance.

Viridian Therapeutics, Inc. participates in E-Verify for employment eligibility verification.

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Medical Director/Sr Medical Director, Drug Safety & Pharmacovigilance

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