Description

At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. 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.

The Sr. Manager/Associate Director, Drug Safety & Pharmacovigilance will lead a variety of core medical safety activities within the safety organization to support the monitoring and evaluation of the safety profile of assigned products on a global scale. Reporting to the Sr. Medical Director, Drug Safety & Pharmacovigilance, this position requires an experienced and accomplished safety expert who can provide functional, managerial and technical expertise while collaborating with multiple stakeholders. The role will also support broader development efforts including contributions to Safety Operations and Safety Science activities.

Responsibilities:

• Provide medical and scientific expertise in all aspects of Drug Safety and Pharmacovigilance, including contribution to the ongoing worldwide signal detection monitoring, product risk-benefit assessment, and safety assessment activities of assigned products/indications.
• Assist the Sr. Medical Director, Drug Safety & Pharmacovigilance in implementing the overall clinical strategy for lead programs from development, through regulatory submissions and post-commercialization, with an emphasis on mid to late stages of development and commercial products.
• Design and implement safety strategy for clinical studies, including regular review of safety data and responses to safety issues.
• Assist in clinical data review, analysis, and interpretation from a variety of sources to enable program go/no-go decisions.
• Assist in the review of study documents and protocols, regulatory materials, and interpret clinical study data. 
• Coordinate safety outputs from the clinical and safety database for signaling activities and for ad hoc requests.
• Contribute to RSI creation and its revisions.
• Accountable for Aggregate Report coordination including scheduling, planning, management of preparation activities, and drafting of assigned safety portions.
• Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including contributing authorship and review of Investigator Brochures, DSURs, development plans, clinical protocols, INDs/CTAs, regulatory responses, and risk management plans.
• Coordinate and participate in the development of ad-hoc Health Authority responses.
• Review SUSARs, assure outputs from the safety database as well as timely completion of the Analysis of Similar Event Summaries for FDA submissions.
• Liaise effectively within Pharmacovigilance and with other cross-functional departments.
• Monitors safety risk minimization measures.
• Assist in covering the needs of medical affairs by helping lead the continued development and execution of a Medical Affairs strategy, including external stakeholder management, communication, patient identification, evidence generation, publications, and medical education.
• Perform other duties as assigned.

Requirements

• Advanced Degree (M.D. PhD, MPH, PharmD). Medical Doctor Degree Preferred. 
• 5 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.
• Knowledge of Aggregate Report requirements and experience in the creation of DSURs, PSURs, NDA Periodic Reports, and IND Annual Reports.
• 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.
• Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus).
• Working knowledge of Risk Management requirements and activities.
• Thorough understanding of the drug development process and context applicable to safety surveillance activities.
• Development and review of SOPs and Work Instructions.
• Vendor Management oversight responsibilities
• 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. 
• Approximately 10-15% travel may be required.
• Viridian offers a flexible work environment. This position can be fully remote, or a hybrid work model based out of our Waltham, MA or Boulder, CO locations. Travel to sites and meetings is required. 

Compensation: The salary range for this position is commensurate with experience. Viridian offers a comprehensive benefits package including:

• Remote work with technology tools and infrastructure
• 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
• Company paid insurance 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 Viridian

Viridian 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 Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.