Director, Pharmacovigilance Operations

The Director, Pharmacovigilance (PV) Operations at Dyne is responsible for tactical and strategic aspects of PV operations activities involving Dyne programs. This individual is accountable for ensuring compliance with and continuous improvement of Dyne PV process related to safety governance, management of individual case safety reports, aggregate reporting, signal detection, implementation of safety language in clinical trial and regulatory documents, and corporate training on safety SOPs and Policies. Oversight of the Pharmacovigilance Service Provider (PSP) is a key aspect of this role. This role partners closely with the Head of PV in the implementation of signal detection plans and be an integral member of study teams across Dyne programs. Ultimately, this position is accountable for resourcing, development, training, and management of a high-performing PV operations team.

• Provide strategic planning, implementation, and management of Dyne Pharmacovigilance Operations activities
• Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and EU Good Pharmacovigilance Practice (GVP)
• Responsible for managing external PV vendors, and internal staff (when added) related to PV operational activities, creating a highly efficient team across insourced and outsourced resources commensurate to the needs of Dyne clinical programs
• Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and configurations in the PV database to accommodate these trials and products, including specific workflows and reporting/querying functionalities
• Build and implement pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations
• Responsible for successful oversight of systems and MedDRA updates in collaboration with the relevant vendor(s)
• Responsible for compliant and quality execution of all operational activities related to safety case management and related PV activities, and participation in safety case review
• Oversee and ensure timely submissions of expedited reports to the FDA & other health authorities and to EC/IRBs via external vendors
• Effectively collaborate with key stakeholders at all levels in the organization and represents PV Operations on program teams and applicable governance committees
• Support, with Dyne Data Management, reconciliation activities performed by the PSP between the safety DB and the clinical database
• Assist in the preparation and management of aggregate safety reports (e.g., IND safety reports, DSURs, PSLLs etc.)
• Assist with the development, implementation, maintenance, and continuous improvement of pharmacovigilance related SOPs, policies, and work instructions
• Create and track PV Operations-related metrics, e.g., case processing, for internal monitoring of performance of the PV function
• Participate in the development and implementation of an inspection readiness program with the contribution of other PV and non- PV stakeholders including the quality function
• Participate in regulatory inspections/audits as they relate to PV activities
• Work with QA department to maintain a state of high PV inspection readiness across all regions/countries
• Work with QA to ensure root cause analysis of any deviations from PV process, and the implementation of effective corrective and preventative action plans for any PV-related quality issues

• Minimum of 10 years of experience in the pharmaceutical industry or CRO, with in Pharmacovigilance Operations in the biopharmaceutical industry, with at least 5 years of leadership and managerial experience in overseeing global/regional PV operations
• Bachelor’s degree in life sciences, pharmacy (RPH or PharmD), nursing (RN, BSN, MSN or NP), PA or equivalent health experience, advanced Life Sciences Degree or MBA preferred
• Experience in the management of safety information originating from clinical trials and post-marketing sources, including end-to-end management of individual case safety reports
• Experience leading and building PV Operations teams is preferred
• Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines
• Thorough knowledge of pharmacovigilance regulations in US (CFR) and Europe (GVP)
• Detailed knowledge of drug safety databases, particularly Aris-G or ARGUS
• Experience working with MedDRA for drug coding
• Significant experience working with PV vendors including oversight and management experience
• Must have excellent interpersonal skills, ability to develop important relationships with key stakeholders at all levels of management, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations
• Strong verbal and written communications and presentation skills
• Proven problem solving and decision-making skills
• Possess strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
• Proven ability to work on multiple projects in a fast-paced environment.

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