Associate Medical Safety Director, Lifecycle Safety

IQVIA; Oeiras; On-site; EUR 90,000 - 120,000; Full time

Job summary

IQVIA’s Lifecycle Safety Medical team in Portugal seeks an Associate Medical Safety Director to lead medical safety activities, oversee signal detection, benefit-risk evaluation, and regulatory reporting for assigned portfolios.

You will provide pharmacovigilance expertise, mentor teams, and ensure compliant safety oversight across study protocols, post-marketing analyses, and safety communications with health authorities.

Qualifications

• Medical degree from an accredited and internationally recognized medical school
• Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including safety and good clinical practice and trials
• Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature
• Experience in Signal detection, Aggregate reports and Risk management.
• Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
• Ability to establish and meet priorities, deadlines, and objectives
• Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure and be flexible
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed

Responsibilities

• Providing aggregate reviews of safety information to maintain oversight of a product’s safety profile
• Leads signal detection and analysis, signal detection strategy, frequency and timing
• Providing medical review and contribution to regulatory reports (IND, EU/US safety reports)
• Providing medical review and contribution to development risk management plans and risk strategies
• Review and contribute to benefit-risk evaluation of drugs in clinical trials and post-marketing
• Providing safety oversight and contribution for label development and updates
• Provide medical safety contributions to safety summaries or regulatory documents
• Performing medical review of trial-related adverse events and post-marketing ADRs, including causality and seriousness
• Representing safety findings in internal and external stakeholder meetings
• Providing medical safety support at Safety Governance meetings

Skills

Signal detection

Aggregate reports

Risk management

Data synthesis & writing

Prioritization & deadlines

Mentorship

Team collaboration

Education

Medical degree from accredited medical school

Clinical practice: ~3 years with 2+ years in pharma

Knowledge of regulatory guidelines (GCP, safety)

Job description

IQVIA’s Lifecycle Safety Medical team in Portugal seeks an Associate Medical Safety Director to lead medical safety activities, oversee signal detection, benefit-risk evaluation, and regulatory reporting for assigned portfolios.

You will provide pharmacovigilance expertise, mentor teams, and ensure compliant safety oversight across study protocols, post-marketing analyses, and safety communications with health authorities.