Associate Medical Safety Director (Home-Based)

About the role

The ever-growing Lifecycle Safety Medical team is expanding, and the Associate Medical Safety Director (home-based) takes part in all aspects of Medical Safety activities. The role provides and maintains post-marketing safety expertise for internal and external stakeholders, keeps up to date on allocated product portfolios, and acts as an internal consultant for medical support of pharmacovigilance operations.

Key responsibilities

• Provide aggregate reviews of safety information, including clinical data, to oversee a product's safety profile
• Lead signal detection and analysis, including strategy, frequency and timing, and contribute to safety analysis reports
• Contribute to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports and US Periodic Reports
• Contribute to Development Risk Management Plans, EU Risk Management Plans and US Risk Evaluation and Mitigation Strategies
• Support benefit-risk evaluation of drugs in clinical trials and after marketing, and contribute to label development and updates
• Contribute to the Integrated Safety Summary or Common Technical Document
• Review and clarify trial-related adverse events and post-marketing adverse drug reactions, including narrative, coding, expectedness, seriousness and causality
• Represent safety and clinical data findings in internal and external stakeholder meetings and attend Safety Governance and other meetings

Required profile

• A medical degree from an accredited, internationally recognized medical school
• Approximately three years of clinical practice, plus two additional years in the pharmaceutical or associated industry, or an equivalent combination of education, training and experience
• Knowledge of applicable federal and local regulations and guidelines on clinical research, safety, good clinical practice and clinical trials
• Maintained knowledge of the assigned product portfolio, therapeutic area and recent literature

Required skills

• Signal detection, aggregate reports and risk management
• Ability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues orally and in writing
• Ability to work under pressure, meet priorities and deadlines, and adapt to changing business needs

The potential base pay range is EUR 53,000 to EUR 90,200 per year, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.