Assoc Medical Safety Dir Lisboa

Assoc Medical Safety Dir
Lisboa
Lisboa, Lisboa, Portugal

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Associate Medical Safety Director

We are looking for an Associate Medical Safety Director to provide medical, scientific, and therapeutic expertise on pharmacovigilance services. Responsibilities include:

• Performing medical review and clarification of
  - related Adverse Events (AEs) and
  - marketing adverse drug reactions (ADRs), including analysis, medical evaluation, and review of safety data.
• Reviewing and editing analyses of similar events (AOSE) for expedited cases based on regulatory requirements.
• Serving as an internal consultant to pharmacovigilance case processing teams.
• Providing aggregate reviews of safety information and clinical data to oversee a product’s safety profile.
• Reviewing medical coding of AEs, medical histories, medications, and other data.
• Representing safety findings during client meetings.
• Reviewing and editing safety reports such as IND Annual Reports, EU and US safety reports, and risk management plans.
• Providing medical oversight for label development and safety monitoring activities.
• Supporting attendance and medical evaluation at Data Safety Monitoring Board Meetings and Safety Monitoring Committees.

Qualifications:

• Medical degree from an accredited and recognized medical school.
• Approximately three years of clinical practice experience plus two years in the pharmaceutical industry.
• Knowledge of regulations and guidelines pertaining to clinical research, safety, and good clinical practice.
• Understanding of clinical trials and pharmaceutical research processes.
• Experience in risk management, signal detection, and aggregate reporting.
• Ability to prioritize, meet deadlines, and handle multiple assignments.
• Strong consultation, communication, and
  - building skills.

IQVIA is a leading global provider of analytics, technology solutions, and clinical research services to the life sciences industry. We aim to push the boundaries of human and data science to create a healthier world. Learn more at our website.