Senior Director, DSPV Medical Safety

Job Description:

Overview

The Senior Director is the DSPV medical expert for assigned products and maintains current knowledge of assigned product portfolio and safety profiles. This individual will provide the day-to-day direction to the Medical Safety Team to ensure business needs and priority tasks are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety surveillance, risk management, and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports and safety documents, including labeling changes. This role provides DSPV support for internal and external customers. This position reports to the Executive Director (ED), DSPV and will provide coverage for the ED, DSPV during his absence.

Responsibilities

• Leads strategic consultation, and guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, interpretation and appropriate management and communication of safety information for Insmed’s portfolio of products in development. Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds.
• Delivers high quality and timely medical safety deliverables. Provides content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. Responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information.
• Leads the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds.
• Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Works with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Delivers key content of Risk Management documents (RMPs, REMS) of assigned products.
• Writes periodic reports for assigned products; provides medical interpretation, review, and approval for required reports.
• Shares DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Provides expert safety input to the clinical development program for assigned products and development compounds
• Leads the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develops/provides input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator’s Brochure and Risk Management Plans (RMPs), and Risk-Evaluation and Mitigation Strategies (REMS).
• Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and communication of the safety profile of assigned products and development compounds.
• Prepares responses to inquiries from regulatory authorities on safety issues for assigned products. Leads the integrated safety input into all regulatory documents where required.
• Performs detailed assessment of safety profiles for Due Diligence project.
• Provides Drug Safety input for product recall issues or Health Hazard Evaluations and “Dear Health Care Provider” letters.
• Performs the medical review of all adverse event reports for seriousness, expectedness and causality.
• Maintains and evaluates Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, creating an action plan, and communicating metrics to appropriate teams and individuals. Identifies concerns and champions issue resolution.
• Leads all aspects of medical safety and pharmacovigilance activities conducted in partnership with external business partners or outsource to vendors and contract research organizations (CROs).
• Evaluates, monitors, and oversees strategic drug safety company policies and regulatory requirements on safety data reporting, collection, surveillance activities, and documentation.  Ensures that safety-related project landmarks are met within required timelines.
• Reviews scientific literature and identifies case reports that meet criteria for entry into the safety database; identifies relevant safety articles / references involving the active ingredients of marketed products and products in development; and builds literature summary sections to be included in PSURs and other required reports.
• Ensures audit and inspection readiness of the function at all times.

Job Requirements:

• M.D. or D.O. required; MPH (Master of Public Health) is a plus.
• 2+ years of Clinical Patient Care experience strongly preferred.
• 8+ years of pharmaceutical industry experience within Drug Safety/Pharmacovigilance working with both investigational and marketed products.
• 5+ years of demonstrated experience with medical case reviews, aggregate reporting, safety surveillance, signal management, and/or risk management.
• Ability to review and/or prepare scientific or regulatory documents from large volumes of scientific information.
• Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. A background in providing product defense before a national or international regulatory authority is a plus.
• Must have excellent communication skills (verbal and written).
• Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines is strongly desired.
• Experience in drug development and clinical trial methodology with rare disease experience preferred.
• Experience in preparing clinical safety assessments and regulatory reports/submissions involving safety information.
• Experience leading roles in clinical or safety through the complete submission process.
• Experience in presenting clinical or safety data to major health authorities.
• Strong leadership skills including mentoring, motivating, directing, and fostering collaboration.
• Experience in leading cross-functional, multi-cultural teams.
• Ability to develop and maintain effective working relationships with subordinates, superiors, and peers.
• Strong negotiation and conflict management skills.
• Drug safety database knowledge preferred.
• Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat digital literacy.

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