Sr. Manager/AD, Drug Safety & Pharmacovigilance

Description

  

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the VP, Clinical Development (interim), the Sr. Manager/AD, 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. 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.

This role may be remote or based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to):

• 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 VP, Clinical Development 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 and medical 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, 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 SAEs and 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
• Support preparation and management of safety teams and meetings (eg, Safety Management Team, DSMBs)
• 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

  

• Requires an advanced degree (M.D. PhD, MPH, PharmD); Medical Doctor degree preferred
• Requires 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<