Clinical Study Manager

4 weeks ago

Uxbridge, United Kingdom Parexel Full time
Job Title: Senior Medical Director

Parexel is seeking a highly experienced Senior Medical Director to lead our Safety Medical Sciences business functions and provide strategic inputs to Safety Services Leadership.

Job Purpose:

The Senior Medical Director will be responsible for providing leadership and direction to the Safety Medical Sciences business functions, including resource management, overall quality, business continuity, utilization, and profitability.

Key Responsibilities:
  • Responsible for maintaining an excellent knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines.
  • Maintaining an excellent awareness of global regulatory requirements, reporting obligations, and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
  • Overall responsible for quality of the function and function's Key Performance Indicators (KPIs) targets.
  • Performing medical review of cases, including non-serious and serious spontaneous cases, clinical trial cases, and literature cases, according to client/Parexel Standard Operating Procedures (SOPs).
  • Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assessing company causality.
  • Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, and reviewing narrative.
  • Reviewing and/or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs.
  • Reviewing and signing off Data Management line listings.
  • Providing input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
  • Managing safety signals on project-specific tools.
  • Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues.
  • Preparing and reviewing periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE, and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs.
  • Supporting the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels, and Development Core Safety Information (DSCI).
  • Providing safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents.
  • Contribute to regulatory agency submissions by reviewing safety data and preparing relevant sections of the filing documents and submission packages.
  • Participating in or providing input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
  • Therapeutic Area Head (TAH) provides PV expertise, leadership, mentorship, and supervision of involved Therapeutic Area members and personnel assigned to the respective organization to ensure appropriate assessment of Safety information related to assigned products/portfolio.
  • TAH oversees compliance, quality, procedures, regulations, timeliness, and consistency of all deliverables, including Scheduled Reports, Ad Hoc Reports, and Signal Management.
  • Management of Safety Officers, Signal Management Expert(s), Risk Management Expert(s), PV Scientist(s), and administrative assistants.
  • Overseeing continuous evaluation of safety and benefit-risk assessment activities and strategies for the Therapeutic Area.Requirements:
    • Extensive drug safety and clinical trial knowledge and experience.
    • Very strong knowledge/understanding of medical terminology.
    Education:
    • Doctor of Medicine (MD)/Medically qualified from an acknowledged Medical School.
    • Completion of at least a basic training in clinical medicine (residency, internship, etc.).

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