General Scope and Summary
SAGE Therapeutics is searching for an experienced PV Scientist that is a creative, resourceful, and integrative thinker. The person in this role works closely with the Executive Medical Director of Drug Safety and Pharmacovigilance (DSPV) and provides pharmacovigilance and risk management support for the assigned investigational and/or marketed products. Effective communication skills will be key, as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Regulatory Affairs, and Medical Affairs. The PV Scientist will provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal detection and management activities, safety and benefit-risk evaluation for assigned products, management of potential safety issues for assigned products, drafting of responses to regulatory inquiries on product safety issues, and aggregate safety reporting for assigned products.
Roles and Responsibilities
Perform product safety surveillance activities for assigned product(s) during all phases of the product life cycle.
Maintain knowledge of Sage therapeutic area diseases and assigned product(s) safety and efficacy profile.
Ensure that routine signaling activities assessment and investigation are completed and documented per SOPs.
Support Sage Safety Governance product safety and benefit risk discussions and presentations.
Provide DSPV representation for clinical development of the assigned product(s), including:
Clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis, and reporting of study data.
Partner with the DSPV Medical Lead and Medical Sciences on safety monitoring of trial subjects as applicable.
Respond to safety-related queries IRBs/ECs.
Support clinical trial safety data review activities (EDC periodic data review, AE queries, review of TLFs, etc.)
Safety content of IB, Reference Safety Information, ICF.
Clinical study reports.
Lead the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant safety sections.
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.
In conjunction with DSPV Global Medical Lead, contribute towards new drug application (NDA), safety queries from regulatory authorities, 120-day safety update, and other safety regulatory activities as 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.
Advanced degree (RN, PharmD, NP, PhD, MD, MPH, NP, or DVM with specialty board certification).
6+ years of pharmacovigilance experience, including experience in aggregate safety reports and safety signal detection and management.
Expertise in the following: Argus Safety Database, MedDRA, Sharepoint, Microsoft Office, and Excel.
Prior experience in clinical trials safety and seasoned skills on signal detection and management would be desirable.
A proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency.
Ability to review, synthesize, analyze, and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information.
Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing.
Demonstrated collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.
Level will be commensurate upon experience and qualifications.
Excellent oral and written communication skills.
Prior experience contributing to the development of drug safety process improvement, training, etc. would be desirable.
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:Contingent WorkerNumber of Openings:1Job ID:R001402#Biotechnology #Careers #ThisIsSage
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.
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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.