• Job Description

  Req#: R002072

  General Scope and Summary

  SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for providing pharmacovigilance and signal detection expertise through contributions to clinical and post-market pharmacovigilance deliverables and activities. The Director, DSPV Scientist will provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, safety and benefit-risk evaluations for assigned products, management of potential safety issues for assigned products, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues, including oversight of aggregate reporting for all assigned products. A demonstrated ability to assimilate clinical data, perform thorough analyses/review, make crisp assessments, and communicate effectively, both verbally and in writing, play a critical capability in this job.

  Roles and Responsibilities

  Product Oversight:

  • Oversee aggregate reports production, clinical trial and post-marketing activities, signal management, literature review, and ad hoc regulatory responses for assigned product group.

  • Lead product safety surveillance activities for assigned product(s) during all phases of the product lifecycle (includes both investigational and marketed products).

  • Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor.

  DSPV Scientist Support During All Phases of the Product Lifecycle:

  • Participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB/DMC activities, and coding review as well as SAE reconciliation activities.

  • Review study protocols, statistical analysis plans, and other clinical study-related documents.

  • Review standard design of tables, figures, and listings for safety data from clinical studies.

  • Provide key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review, and approval for filing related activities.

  • Manage updates to Investigator Brochure, Company Core Safety Information, and other Reference Safety Information.

  Support for Aggregate Reports, Risk Management Plans, and REMS Activities:

  • Demonstrate effective leadership skills with cross-functional partners to ensure that safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines.

  • Lead PSUR/PADER/DSUR strategy, preparation, and adherence to timelines with key stakeholders and vendors.

  • Support RMP updates as appropriate for the assigned product(s).

  • Contribute to the development of Risk Evaluation and Mitigation Strategies (REMS) or REMS amendments.

  • Support preparation of REMS assessment reports by contributing to the safety relevant sections.

  Signal Detection and Management:

  • Implement signal detection strategy approved by the Vice President, Drug Safety and Pharmacovigilance (DSPV) and Safety Review Committee (SRC).

  • Review adverse event data, literature, and other safety-relevant data for signal detection.

  • Prepare review of potential safety signals for the Vice President, DSPV.

  • Perform signaling review and the coordination and documentation of all signal review activities with the product safety physician and product complaint staff. This includes performing signal investigations and drafting signal investigation reports.

  • Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the product safety physician, Biostatistics, and others as needed, including performing analysis and drafting of query responses for review and finalization.

  • Support in preparing Safety Committee slides and documenting of meeting minutes.

  Departmental Procedures and Compliance:

  • Ensure that PV activities remain compliant with evolving regulations, as well as that respective SOPs and work instructions regarding signaling, ad hoc, and aggregate safety and risk management plans are adequate.

  • Assist in the successful implementation, execution, and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards, and compliance with global regulations.

  • Stay updated on relevant regulations associated with the above activities. Contribute to initiatives for process improvement and cross-product process consistency.

  • Facilitate inspection readiness activities, if applicable.

  Experience, Education and Specialized Knowledge and Skills

  Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a 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.

  The Sage team leads the development of innovative products and solutions, knowing that integrity is a core value throughout our company. Sage will offer the successful applicant a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for our patients’ lives.

  Basic Qualifications

  • RN, PharmD, NP, MD, MS, or DVM preferred.

  • Relevant life science background and 8-10+ years of experience in drug safety serving in a PV Scientist or similar role.

  Preferred Qualifications

  • Demonstrated experience in the analysis and interpretation of medical and scientific data, as well as excellent verbal and written skills. Experience in safety surveillance systems, aggregate reports, case management, and global regulatory processes, ensuring quality and compliance with regulations.

  • Demonstrated ability to provide strategic input in preparation of responses to Regulatory Authority(ies), authoring of safety topic report, and aggregate report preparation.

  • Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.

  • Strong organizational, project management, and leadership skills: lead and conduct, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.

  • Oversee and mentor less experienced PV Scientist staff.

  • Apply clinical judgment to interpret case information.

  • Solid knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. This includes familiarity with case processing, expedited reporting rules, and safety database concepts.

  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

  • Strong team player that has a customer service approach and is solution-oriented.

  • 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, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

  • Excitement about the vision and mission of Sage.

  Employment Type:

  Employee

  Number of Openings:

  1

  Job ID:

  R002072

  #Biotechnology #Careers #ThisIsSage

  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.

  Equal Opportunity Employer. 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.

  EEO is the Law

  EEO is the Law - Supplement

  Pay Transparency Nondiscrimination

  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.

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• About the company

  Learn more about Sage Therapeutics, a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain.

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