General Scope and Summary
SAGE Therapeutics is searching for an experienced Manager, Pharmacovigilance (PV) Operations that is a creative, resourceful and integrative thinker. This position is responsible for creating, directing and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance system and adheres to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to SAGE case management, data review, document development and review including procedures for the accurate and timely processing, review and reporting of adverse events from investigational SAGE compounds and SAGE marketed products. In addition, this position must build and maintain relationships with key strategic internal and external stakeholders including the hiring and training of PV personnel.
Roles and Responsibilities
- Responsible for managing internal and external staff allocated to operational PV activities, creating a highly efficient team across insourced and outsourced resources.
- Contribute to the development of global Medical Safety/Pharmacovigilance strategies with the Head of the PV group.
- Builds and implements local U.S. pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations.
- Contribute to the selection of PV vendors to support an outsourced PV business model. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
- Establish a system for prevention and correction of deviation to compliance with internal and external stakeholders, in collaboration with the PV Quality, Compliance and Safety Systems group and internal QA group.
- Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
- Develop and/or maintain a set of SOPs related to the processing and reporting of SAEs from clinical trials and marketed products to ensure performant and compliant PV processing, integrated with other PV and non PV SOPs.
- Contributes to the signal detection, benefit-risk profile assessment and aggregate reporting activities with providing accurate reports from the PV database.
- Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversees timely submissions of expedited reports to the FDA & other health authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
- Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
- Ensures that the PV Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant PV Vendor.
- Represents drug safety as a leader on project teams, other departments, and committees as needed.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience, advanced Life Sciences Degree or MBA preferred
- Minimum of 5-7 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry; minimum 3 years in managerial role in drug safety
- Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
- Through knowledge and experience in all aspects of safety reporting for clinical trials and marketed situations.
- Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.
- Operational expertise with ARGUS preferred.
- Level will be commensurate upon experience and qualifications
- Excellent oral and written communication skills
- Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
- Excitement about the vision and mission of Sage