Medical Director, Pharmacovigilance

DescriptionAt Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases, and we are getting closer to achieving this goal every day.Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. Reporting to the Senior Vice President, Pharmacovigilance, the Medical Director, Pharmacovigilance will serve as an experienced safety physician responsible for providing medical leadership across core pharmacovigilance activities for assigned investigational and/or marketed products. The role is responsible for safety surveillance, signal detection and evaluation, benefit-risk assessment, aggregate safety reporting, medical review of individual cases, and regulatory safety deliverables. This position will partner closely with clinical development, clinical operations, biostatistics, regulatory affairs, medical affairs, quality, and external vendors/CROs to ensure high-quality, timely, and compliant safety oversight across clinical development programs, including ongoing and planned Phase 3 clinical trials.This role may be remote or based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. For a remote role, travel to headquarters may be required at discretion of management.Responsibilities (including, but not limited to):Provide medical and scientific leadership for pharmacovigilance activities supporting assigned products and indications, including ongoing safety surveillance, signal detection and evaluation, benefit-risk assessment, and safety strategy development.Lead or co-lead Safety Management Team activities for assigned programs, including preparation of agendas, review of emerging safety data, interpretation of clinical and nonclinical findings, documentation of decisions, and follow-up of safety actions.Apply medical judgment to the review and assessment of serious adverse events, SUSARs, adverse events of special interest, cases of clinical interest, and aggregate case trends to support timely and compliant safety reporting.Oversee outsourced pharmacovigilance activities, including medical review, case processing quality, safety database outputs, and vendor/CRO performance, ensuring appropriate escalation and resolution of safety issues.Develop and implement safety monitoring strategies for clinical studies, including review of protocols, informed consent forms, safety management plans, medical monitoring plans, and data review plans.Contribute to clinical data review, analysis, and interpretation from blinded and, when appropriate, unblinded sources to support program decisions, safety governance discussions, and regulatory interactions.Lead or contribute to preparation of pharmacovigilance and clinical safety content for Investigator Brochures, Reference Safety Information, DSURs, PSURs/PBRERs, IND Annual Reports, clinical study reports, regulatory responses, risk management plans, and other safety-related submissions.Coordinate aggregate safety report planning and execution, including timeline management, data review, authoring of assigned safety sections, cross-functional review, and quality control of medical content.Partner with clinical development, regulatory affairs, biostatistics, clinical operations, medical affairs, quality, and other stakeholders to identify, evaluate, communicate, and mitigate emerging safety risks.Support development, implementation, and monitoring of risk minimization measures, safety governance decisions, and product-level benefit-risk management activities.Coordinate and contribute to ad hoc Health Authority responses, safety queries, and inspection/audit readiness activities related to assigned programs.Provide medical safety input to standard operating procedures, work instructions, safety conventions, and process improvement initiatives within the pharmacovigilance function.Liaise effectively with internal and external stakeholders, including CROs, pharmacovigilance service providers, medical monitors, study teams, and business partners, to ensure alignment on safety expectations and deliverables.Provide medical support and coverage to non-medically qualified QPPV, deputy QPPV, or other pharmacovigilance colleagues as needed.Mentor and provide guidance to pharmacovigilance team members and cross-functional colleagues on medical safety assessment, documentation quality, and regulatory expectations.Perform other duties as assigned.RequirementsMedical Doctor Degree required. 7+ years of pharmacovigilance/related experience, including experience in aggregate safety reports, safety signal management/detection activities, critical review of safety data, case processing of SAEs, and preparing other regulatory documents.Experience preparing and contributing to aggregate safety reports, including DSURs, PSURs/PBRERs, IND Annual Reports, and other regulatory safety submissions.Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments.Thorough knowledge of relevant EU GVP, FDA and ICH guidelines, including Good Clinical Practices (GCP) guidelines.Experience utilizing safety databases and coding dictionaries, including Argus, MedDRA, and WHO Drug Dictionary, to support safety surveillance and reporting activities.Experience supporting risk management activities, signal evaluation, benefit-risk assessments, and safety monitoring strategies for clinical programs.Strong understanding of the drug development lifecycle and the role of pharmacovigilance within clinical development and regulatory decision-making.Experience developing, reviewing, and maintaining SOPs, work instructions, and pharmacovigilance processes to support compliance and operational effectiveness.Experience working with and overseeing CROs, vendors, and external service providers to ensure quality, compliance, and timely deliverables.Participation in clinical study team meetings and activities.Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities.Excellent verbal and written communication skills including the ability to present to both internal and external partners.Hands-on style with proven ability to work in an entrepreneurial environment and ability to manage and outsource work as required. Strong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Approximately 10-15% travel may be required.The salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:· Competitive pay and stock options for all employees· Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents· Fertility and mental health programs· Short- and long-term disability coverage· Life, Travel and AD&D· 401(k) Company Match with immediate company vest· Employee Stock Purchase plan· Generous vacation plan and paid company holiday shutdowns· Various mental, financial, and proactive physical health programs covered by ViridianViridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.Employee Type: FT Exempt