Associate Medical Safety Director – Sponsor Dedicated

🔥 13 hours ago

🇷🇴 Romania – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Participate in all aspects of Medical Safety activities according to scope of work • Provide and maintain pharmacovigilance and risk management expertise for internal and external stakeholders • Maintain knowledge relevant to allocated product portfolios • Conduct medical evaluation of post-marketing adverse drug reactions • Review and contribute to signal management and benefit-risk evaluation for drugs in clinical trial and post-marketing settings • Prepare and/or contribute to responses to health authority questions • Review and contribute to periodic aggregate reports • Contribute to safety review of study protocols, investigator brochures, and other reference safety information • Serve as an internal consultant for medical support of pharmacovigilance operations • Provide aggregate reviews of safety information, including clinical data, to maintain oversight of product safety profiles • Lead signal detection and analysis, including detection strategy, frequency, and timing; review Signal Detection Reports and other data sources; raise potential signals for team discussion; and contribute to safety analysis reports and presentations • Provide medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, and US Periodic Reports • Provide medical review and contribution to Development Risk Management Plans, EU Risk Management Plans, and US Risk Evaluation and Mitigation Strategies • Review and contribute to benefit-risk evaluations of drugs • Provide safety oversight and contributions for label development, review, and updates • Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document • Perform medical review and clarification of trial-related adverse events and post-marketing adverse drug reactions, including narratives, queries, coding, expectedness, seriousness, causality, and company summaries • Serve as an internal consultant to pharmacovigilance case-processing teams • Represent safety and clinical data review findings in internal and external stakeholder meetings • Provide medical safety support, contributions, and attendance at Safety Governance and other meetings as needed

🎯 Requirements

• A 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, or equivalent combination of education, training and required experience • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research, safety, good clinical practice, clinical trials, and pharmaceutical research processes • 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; capacity to work under pressure; initiative, flexibility, and ability to adapt to changing business needs • Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed