Associate Medical Safety Director- Sponsor Dedicated
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 of 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, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, 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, and serving as an internal consultant for any medical support for pharmacovigilance operations.
Associate Medical Safety Director
Role responsibilities:
Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports 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
Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up
Providing safety oversight and contribution for label development, review, and updates
Provide 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) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams
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
Do you have the skills, experience and qualification required for the role:
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 knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process
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 as well as initiative and 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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.