General Scope and Summary
Sage Therapeutics is searching for an experienced Senior Director of 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 overall safety operations strategy across the portfolio including SAGE case management, database strategy, vendor oversight, compliance, inspection readiness, contracts and training. In addition, this position must build and maintain relationships with key strategic internal and external stakeholders including the hiring and training of Drug Safety and Pharmacovigilance personnel.
Roles and Responsibilities
- Provide strategic planning, implementation, and management of DSPV Operations activities.
- Responsible for managing internal and external staff allocated to operational DSPV activities, creating a highly efficient team across insourced and outsourced resources.
- Provides 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 Good Pharmacovigilance Practice (GPvP).
- Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations.
- Ensures that the DSPV Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant DSPV vendor.
- Contribute to the selection of DSPV vendors to support an outsourced DSPV business model. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
- Develop and implement an inspection readiness program with the contribution of other DSPV and non-PV stakeholders
- 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.
- Establish a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Sage Quality 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.
- Contributes to, drafts and implements department SOPs and work instructions related to the DSPV activities.
- Contributes to the signal detection, benefit-risk profile assessment and aggregate reporting activities with providing accurate reports from the DSPV database.
- Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices.
- Represents DSPV 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 8-10 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry; minimum 6 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
- Thorough 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