[Hiring] Associate Medical Safety Director @IQVIA

Role Description

Our ever-growing Lifecycle Safety Medical team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to:

• Providing and maintaining PV and risk management expertise to internal and external stakeholders
• Maintaining knowledge relevant to allocated product portfolios
• Conducting medical evaluation of post-marketing adverse drug reactions
• Reviewing and contributing to signal management and benefit-risk evaluation of drugs in clinical trial and post-marketing setup
• Preparation and/or contribution to responses to questions from health authorities
• Reviewing and contributing to periodic aggregate reports
• Contributing to safety review of study protocols, investigators brochure, and other reference safety information
• Serving as an internal consultant for any medical support for pharmacovigilance operations

Qualifications

• 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, including safety and good clinical practice
• 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, capacity to work under pressure, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed

Requirements

• Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Leading signal detection and analysis, including signal detection strategy, frequency, and timing
• Reviewing the Signal Detection Reports and other sources of data as applicable
• Raising potential signals for team discussion
• Contributing to safety analysis reports and presentations of signal evaluation data as appropriate
• Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans, or US Risk Evaluation and Mitigation Strategies
• Reviewing and contributing to benefit-risk evaluation of drugs in clinical trial and post-marketing setup
• Providing safety oversight and contribution for label development, review, and updates
• Providing medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
• Representing safety and clinical data review findings during internal and external stakeholder meetings
• Providing medical safety support, contribution, and attendance at Safety Governance and other meetings as needed

Benefits

• The potential base pay range for this role, when annualized, is €53,000.00 - €90,200.00
• The actual base pay offered may vary based on a number of factors including job-related qualifications
• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered
• A range of health and welfare and/or other benefits