Vice President, Drug Safety & Pharmacovigilance
Sage Therapeutics is committed to discovering, developing and delivering novel medicines to transform the lives of patients with life-altering disorders of the central nervous system (CNS). We have opened the door to a whole new way to think about treating disorders of the brain. Sage is a place where unconventional thinking to solve problems with new ideas is welcome – and where unconventional thinkers can imagine what’s possible and do big.
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, strategic leader for a highly visible role responsible for the medical oversight of global pharmacovigilance activities for clinical trials and product development.
Reporting to the Chief Medical Officer, the VP, Pharmacovigilance & Drug Safety will provide leadership to the PV & Drug Safety Team and work cross-functionally to maintain standards for pharmacovigilance and risk management activities to ensure patient safety. This position will have a high degree of visibility and impact across the organization. As Sage is expected to undergo significant growth in the upcoming years, this individual will need the skills to work effectively in a dynamic, cross-functional, global organization.
Role and Responsibilities
- Provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance activities across Sage’s portfolio.
- Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug Safety Department.
- Provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
- Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of potential product signals.
- Ensure ongoing evaluation of the overall safety profile for Sage’s investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
- Support both Medical Science and Clinical Operations teams with respect to safety related issues as required.
- Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
- Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports, final study reports, IB, and other documents, as needed.
- Assess global PV requirements for resources, equipment and systems to maximize efficiency.
- Support development and maintenance of product benefit-risk profile.
- Collaborate with business development team regarding direction for business development plan/strategy.
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 identify issues and raise to key stakeholders in order 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 or related discipline
- Pharmacovigilance experience, including regulatory filing experience, within the biotechnology, pharmaceutical or related industry
- Medical or relevant advanced degree strongly preferred
- 7+ years’ relevant industry experience including experience leading multidisciplinary teams
- Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management)
- Oversight experience of global medical safety activities, operations and risk management strategies in pre and post marketing environments.
- Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
- Robust knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
- Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred.
- Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
- Entrepreneurial, small/high-growth company experience is preferred.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- 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
All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.