Associate Medical Safety Director (m/w/d)

IQVIA; Lisboa; Presencial; EUR 70 000 - 90 000; Tempo integral

Resumo da oferta

A leading global clinical research provider in Lisbon is seeking an Associate Medical Safety Director. This role involves managing all aspects of Medical Safety including pharmacovigilance operations and risk management. Ideal candidates will possess a medical degree, substantial clinical experience, and expertise in signal detection and regulatory compliance. This position offers the chance to contribute significantly to patient safety outcomes in a dynamic environment.

Qualificações

• Approximately three years of clinical practice plus two years in pharmaceutical industry or equivalent experience.
• Knowledge of regulations related to clinical research, safety, and good clinical practice.
• Experience in signal detection, aggregate reporting, and risk management.

Responsabilidades

• Providing aggregate reviews of safety information to oversee product safety profiles.
• Leading signal detection and analysis, including strategy, reviews, and reporting.
• Contributing to safety reports such as IND Annual Reports and EU Periodic Benefit-Risk Evaluation Reports.

Conhecimentos

Medical evaluation of adverse drug reactions

Signal detection

Aggregate reporting

Risk management

Interpersonal skills

Data analysis

Formação académica

Medical degree from an accredited medical school

Descrição da oferta de emprego

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Associate Medical Safety Director (m/w/d), Lisbon

Client: IQVIA

Location: Lisbon, Portugal

Job Category: Other

EU work permit required: Yes

Job Reference: e83a8103800d

Job Views: 5

Posted: 24.08.2025

Expiry Date: 08.10.2025

Job Description:

Our ever-growing Lifecycle Safety Medical team is expanding. The role involves all aspects of Medical Safety activities, including PV and risk management, medical evaluation of adverse drug reactions, signal management, benefit-risk evaluation, and supporting regulatory responses. The candidate will serve as an internal consultant for pharmacovigilance operations.

Role responsibilities:

• Providing aggregate reviews of safety information to oversee product safety profiles.
• Leading signal detection and analysis, including strategy, reviews, and reporting.
• Contributing to safety reports such as IND Annual Reports, EU Periodic Benefit-Risk Evaluation Reports, and US Periodic Reports.
• Reviewing and contributing to development and risk management plans.
• Evaluating benefit-risk of drugs during clinical trials and post-marketing.
• Supporting label development and updates.
• Contributing to safety summaries and regulatory documentation.
• Reviewing adverse events and reactions, including narrative and causality assessments.
• Representing safety data in stakeholder meetings.
• Providing safety support for governance and other meetings.

Candidate requirements:

• Medical degree from an accredited medical school.
• Approximately three years of clinical practice plus two years in pharmaceutical industry or equivalent experience.
• Knowledge of regulations related to clinical research, safety, and good clinical practice.
• Knowledge of product portfolios, therapeutic areas, and recent literature.
• Experience in signal detection, aggregate reporting, and risk management.
• Ability to analyze data critically and communicate effectively.
• Ability to prioritize, meet deadlines, and adapt to changing needs.
• Strong interpersonal and mentorship skills.

IQVIA is a leading global provider of clinical research services, insights, and healthcare intelligence, committed to improving patient outcomes worldwide. Learn more at IQVIA's website.