Medical Director, Pharmacovigilance Consultant

General Scope and Summary

SAGE Therapeutics is searching for an experienced part-time Consultant to serve as the Medical Director of Drug Safety & Pharmacovigilance (DSPV) who is a creative, resourceful and integrative thinker. The Medical Director Consultant will participate in the pharmacovigilance and risk management for assigned investigational products. The incumbent will participate in safety governance, including the identification, investigation, and validation of safety signals, 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 including Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs.

Roles and Responsibilities

• Participate in 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.

  • Respond to safety-related queries from regulatory authorities, IRBs/ECs.

• Participate in product benefit-risk discussions through the safety governance structure.

  • Includes needed actions to update Reference Safety Information or risk minimization actions.

• Participate in clinical development activities for assigned product(s), including:

  • Clinical development planning, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis, and reporting of study data.

  • Safety content of IB, Reference Safety Information, ICF.

  • Regulatory filings (ISS, Benefit-Risk, RMP/REMS as required).

• Review medical-safety sections of aggregate safety reports (DSUR, PSUR).

• Conduct medical review of individual case safety reports (ICSRs) as needed.

  • 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.  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 are key. 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.

• MD, MD PhD, or MD MPH required.

• >5 years of experience in drug safety in the pharmaceutical industry.

• Proven sound clinical acumen and decision making.

• 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 collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.

• Excellent oral and written 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:

Job ID:

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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.

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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.