Medical Director, Pharmacovigilance

  • Contract Duration: 12+ months
  • Clinical
  • Boston, MA

Website Lenox Executive Search


Lenox Executive Search is seeking a Medical Director, Pharmacovigilance to fill a contractual role with one of our pharmaceutical clients. This is a fully remote position. Extensive Pre-NDA and NDA experience is a MUST!

Roles and Responsibilities of a Medical Director, Pharmacovigilance:

  • Lead product safety surveillance activities for assigned product(s) during all phases of the product life-cycle:
  • Maintain knowledge of Company 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:
  • Present 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, and ICF.
  • Respond to safety-related queries from regulatory authorities and IRBs/ECs.
  • Pre-NDA/NDA/Regulatory Filings:
  • 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):
  • Complete appropriate follow-up requests and ensure 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. 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.

Basic Qualifications of a Medical Director, Pharmacovigilance:

  • MD, MD PhD, or MD MPH required.
  • Minimum of 5-7 years of experience in drug safety/clinical safety/benefit-risk management.

Preferred Qualifications of a Medical Director, Pharmacovigilance:

  • 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, 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.
  • Prior experience contributing to the development (process improvement, training, etc.) of a drug safety function would be desirable.
  • Embrace our Core Values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
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– The Lenox Executive Search Team