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ICON plc logo
ICON plc

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.

Medical Director

Medical DirectorMedical DirectorFull TimeRemoteLeadTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

37 days ago

Salary

0

Seniority

Lead

Professional Certificate7 yrs expExperience acceptedEnglish

Job Description

Medical Director

ICON plc

• Provide strategic medical safety leadership and hands-on support for assigned product(s) within a cross-functional environment • Develop safety strategies and deliver accurate, timely, and high-quality safety input for global regulatory submission documents (e.g. ISS, SCS, narratives) for assigned product(s) • Conduct safety signal detection and benefit-risk assessment activities, along with routine and ad-hoc aggregate safety data reviews for assigned product(s) • Lead cross-functional discussions and reviews of existing and emerging aggregate safety data for assigned product(s) • Contribute to the advancement of the overall safety governance framework and related activities • Draft and/or review safety sections of clinical and regulatory documents (including study protocols, IBs, Clinical Study Reports, and ICFs) • Provide medical safety expertise in responses to regulatory authority questions and ensure safety information is complete, accurate, and submitted in a timely manner • Lead the preparation of periodic safety reports (e.g. PSUR, DSUR), ensuring consistency, quality, and appropriate medical safety content • Oversee the medical review and assessment of individual case safety reports (ICSRs) • Confirm reporting criteria and content for expedited reporting and unblinding activities (e.g. SUSARs or urgent safety matters) • Lead or contribute to the preparation and presentation of safety data for Data Safety Monitoring Board (DSMB) meetings • Provide medical safety support during internal audits and regulatory inspections • Assist with the development and maintenance of GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates) • Support adverse event reporting training and cross-functional pharmacovigilance awareness initiatives • Support the preparation and review of pharmacovigilance agreements with clinical development and commercial partners • Participate in cross-functional initiatives and project teams • Perform additional responsibilities as needed to support departmental objectives

Job Requirements

  • MD degree
  • Minimum of 7 years of relevant pharmaceutical/biotech industry experience, including at least 5 years within pharmacovigilance/drug safety (global experience preferred)
  • Clinical practice and/or academic medicine experience is considered an asset
  • Working knowledge of global pharmacovigilance regulations and guidance documents
  • Demonstrated ability to perform medical review and assessment of safety data from multiple sources
  • Experience authoring complex documents and supporting regulatory submissions
  • Knowledge of adverse event reporting systems
  • Experience in epidemiology, biostatistics, clinical development, or medical affairs is considered a plus.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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Found logo

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