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    Director Safety Risk Management - Los Angeles, United States - Green Key Resources

    Green Key Resources
    Green Key Resources Los Angeles, United States

    3 weeks ago

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    Description


    We are searching for a Drug Safety/PV Medical Director MD with 5 years of industry experience to join our biopharma client that has tripled in size over the past few years and is still continuing this impressive growth This is a great opportunity to join a growing company at an exciting time where you and advance your skills and be a part of their continued success in bringing hope to patients with unmet medical needs in multiple therapeutic areas.

    Incumbent to newly added Lead role will perform analysis of safety data, manage risk as well as detect and investigate safety signals and provide medical review of safety reports for pipeline and marketed compounds.

    Experience within Neurology/Neuroscience, Endocrinology, or related therapeutic area is preferred but other complex TA experience within Drug Safety/PV will be considered.

    This role is hybrid and on the West Coast. They will also provide relocation if needed.

    Detailed responsibilities include:

    • Performs safety signal management related activities to detect, analyze, and investigate safety signals
    • Develops and manages risk strategies for all phases and company products
    • Manages on-going product safety in support of the safety governance process
    • Performs aggregate safety data review and interpretation to support safety evaluations
    • Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product labeling, Company Core Data Sheet (CCDS))
    • Authors, reviews, and provides input to safety related regulatory submission documents including periodic safety reports (e.g., DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) and responses to regulatory inquiries
    • Performs medical review of individual case safety reports, including summarization, coding, seriousness, expectedness and Company causality assessment of investigational and/or marketed products
    • Serves as the Safety Physician Lead for designated indications or drug portfolio(s)
    • Participates in multidisciplinary teams involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans
    • Participates in developing processes and conventions for safety surveillance activities

    Requirements:

    • Medical degree (MD) and 5 years of relevant clinical/industry experience required.
    • Experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company with experience in signal management (e.g., signal detection, evaluation, assessment)
    • Excellent oral, written and presentation skills
    • Strong leadership skills
    • Excellent teamwork and interpersonal skills are required
    • Excellent problem-solving, analytical thinking skills
    • Sees broader picture, impact on multiple departments/divisions
    • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
    • Excellent organizational and project management skills
    • Ability to lead and conduct individual safety case report processing, including triage, medical review and safety data summarization and analysis
    • Knowledge of and ability to apply international regulatory authority regulations (especially FDA and EU/EEA)
    • Knowledge of and ability to apply pre- and post-marketing drug safety standards
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