Senior Medical Director

hace 3 días

Alcobendas, Madrid, España Parexel A tiempo completo

Job Summary

Parexel is a leading biopharmaceutical services company that improves the world's health by transforming scientific discoveries into new treatments. We are seeking a highly experienced Senior Medical Director to lead our Safety Medical Sciences business functions and provide strategic inputs to Safety Services Leadership.

Key Responsibilities

  • Represent the function/department at various internal and external forums, contributing significantly to thought leadership activities.
  • Responsible for resource management, overall quality, business continuity, utilization, and profitability of the Safety Medical Sciences business functions.
  • Maintain 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.
  • Maintain an excellent awareness of global regulatory requirements, reporting obligations, and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
  • Attend, provide consultations, and/or present at client/cross-functional meetings along with other stakeholders.
  • Overall responsible for the quality of the function and function's Key Performance Indicators (KPIs) targets.
  • Work in collaboration with the Safety Services Leadership Team and provide strategic and competitive inputs to the department and organization.
  • Perform medical review of cases, including non-serious and serious spontaneous, clinical trial, and literature cases, according to client/Parexel Standard Operating Procedures (SOPs) as applicable and liaising with the client, as required.
  • Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess company causality.
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, and review narrative.

Requirements

  • Extensive experience and involvement in Pharmacovigilance / Drug Safety.
  • Previous team management experience.
  • Potential and desire to grow into a bigger leadership role.

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