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Sage Therapeutics Medical Director Consultant, Pharmacovigilance in EMAIL: Workday@Sagerx.com, Massachusetts
General Scope and Summary
SAGE Therapeutics is searching for an experienced Medical Director Consultant for Drug Safety and Pharmacovigilance (DSPV) that is a creative, resourceful and integrative thinker. The Medical Director Consultant serves as the lead for the pharmacovigilance and risk management of assigned investigational and/or marketed products. This is a highly visible role that will interface across all levels of management and functional areas and is responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned 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, Clinical Operations, Regulatory Affairs and Medical Affairs.
Roles and Responsibilities
Lead 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
Lead product benefit-risk assessment discussions at Safety Governance Committees:
Includes presenting recommended actions for risk minimization and communication, update of Reference Safety Information, safety specific patient monitoring or changes to study design, etc.
Respond to safety-related queries from regulatory authorities
Represent as the safety lead during inspections for assigned product(s) and for relevant processes as the Subject Matter Expert (SME)
Lead 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), periodic data review, statistical analysis, and reporting of study data/topline results
Serve as a key contributor and safety lead towards the IB, Reference Safety Information, ICF
Respond to safety-related queries from regulatory authorities, IRBs/ECs
Work closely with Regulatory and cross-functional colleagues on pre-NDA strategy and planning, briefing books, regulatory authority meeting request documents, responses to regulatory authority questions, etc.
Serve as a key contributor for the ISS and Summary of Clinical Safety
Responsible for medical safety sections of aggregate safety reports (DSUR, PSUR)
Conduct medical review of individual case safety reports (ICSRs):
Includes appropriate follow-up requests and accuracy and timeliness of expedited reports
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
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. This role will require 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. This individual will need 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.
MD, MD PhD or MD MPH required
Minimum of 5-7 years’ experience in drug safety/clinical safety/benefit-risk management
Sound clinical acumen and decision-making
Experience in late phase clinical development, pre-NDA phase, and filing experience towards an NDA/MAA is strongly preferred
A proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency
Ability to review, synthesize, and 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 leadership and collaboration skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization
Excellent oral and written communication skills
Prior experience contributing to the development (process improvement, training, etc.) of a drug safety function is desirable
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
Number of Openings:
#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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