Executive Director, Head of Safety/Pharmacovigilance - Carlsbad, United States - Solomon Page

Description

Our client is looking to fill the role of Executive Director, Head of Safety/Pharmacovigilance. This position is hybrid and based out of the Carlsbad office.

Responsibilities:

• Position will lead as Deputy to Head of Safety and Pharmacovigilance Department with full oversight of Drug Safety Physicians team
• Provide strategic oversight and guidance for safety sections of regulatory documents which include for safety sections of all regulatory documents, including but not limited to NDA/BLA/MAA, PSUR/PBRERs, DSURs, EU Risk Management Plans/REMS and ICFs
• Develops and provides strategy, vision, and direction to Drug Safety Physician Team
• Manage oversight of benefit/risk safety profile of company products through all aspects of product life cycle
• Partners with executive leadership team for the function to provide cohesive direction towards company goals
• Provides input to executive management on drug safety
• Enhance safety knowledge of both company and competitor products
• Responsible for leading product teams and managing all safety concerns
• Provide full oversight to Drug Safety Physician team
• Have a good understanding of safety operations and ensure all relevant SOPs and systems/ processes including vendor oversight responsibilities are in place making for an efficient and compliant organization
• Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments
• Work closely with the labeling committee for CCSI presentation
• Provides safety insights to development of Package Insert and Labeling Updates
• Will serve as chair to Safety Management Team (SMT) meetings for specific products that are assigned.
• Represents the SMT in the Safety Oversight Committee (SOC) meetings; develops and proposes review topics and prepares meeting materials
• Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments
• Work closely with the labeling committee for CCSI presentation
• Provides safety insights to development of Package Insert and Labeling Updates
• Provide active participation in External Safety Monitoring Committees
• Reviews Regulatory and other Health Authority inquiries with the Drug Safety and Safety Scientists teams
• Leads and manages escalation of potential issues to the SMT, ensures internal notification and provides updates
• Leads the review of safety issues data and closure on recommendations
• Leads the formulation of a rapid response procedure, triage of potential issues to Safety Oversight Committee, executes Crisis Management response plan, reviews ongoing issue and plan
• Leads and develops strategic plans for safety differentiation of company products, provides training to employees on product safety profiles/issues, provides input into commercial publications strategy, reviews publications, including abstracts, manuscripts, and speaker presentations, provides input for potential in-licensing opportunities as requested
• Product liaison for assigned products with Legal, Bus Dev, Operations, Marketing, etc., executes appropriate communication of safety data and interpretation to external parties, globally, and facilitates communication with business partners and medical directors in Medical Affairs as required.
• Accountable for safety data as well as reviewing and providing advice on Safety Endpoints
• Responsible for the safety sections of the Development Safety Update Report (DSUR)
• Accountable for development and maintenance of RSIs; contributes to the safety sections of the IB, ICF and updates and manages any needs to reconsent subjects in ongoing trials based on emergent safety data assessment
• Lead negotiations related to drug safety and risk management in pharmacovigilance agreements.
• Provide strategic leadership in safety surveillance for clinical development programs.
• Actively leads safety/PV review of statistical analyses plans and all additional analyses required for NDA/MAA applications, as well as regulatory responses; aligns with safety scientist leads in ensuring output generation for TLFs are in conformity
• Proactively reviews and interprets study safety data, supports Clinical Study Report narrative generation, leads the interpretation-based safety sections of reports; reviews/drafts reports
• Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS
• Leads 120-day update plans and activities
• Serve as a core member to product development team as core team member to represent and promote safety
• Leads the preparations for, and attends, clinical team meetings

Required Qualifications:

• MD (or internationally recognized equivalent) plus accredited residency
• 15+ years' pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development in all phases of clinical trials
• 10+ years' experience in patient safety and pharmacovigilance
• 10+ years prior experience as a lead product safety physician with global experience
• Appropriate experience with Regulatory Agency and KOL interactions
• Prior experience of global regulatory interactions
• Prior experience in a leading role with successful submission and approval of BLA/NDA/MAA and JNDAs
• Pharmaceutical product development experience, including individual study design and filing plans

If you meet the required qualifications and are interested in this role, please apply today.

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About Solomon Page

Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: and connect with us on Facebook , and LinkedIn .

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