At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world's largest provider of product development and integrated healthcare services.
As one of FORTUNE's 'Most Admired Companies' in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.Description
Apply knowledge and contribute to Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, and signal management activities.
- Serve as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements.
- Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs, DSURs, PADERs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required.
- Contributes in the conduct of ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
- Provide assistance in signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked.
- Interface with other functional groups within Lifecycle Safety and other business units, such as Regulatory Affairs, RWLP, Medical Writing, Clinical Research, Quality, and Information Technology, as needed.
- Participate in internal and external audits, as required.
- Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
- Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
- Conduct ongoing literature safety surveillance for marketed and investigational products to identify individual case safety reports from the literature, evaluation of events of special interest as well as aggregate report data review.
- • Excellent knowledge of Lifecycle Safety services and processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
- • Good understanding of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs).
- • Proven ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands.
- • Excellent organizational skills and time management skills.
- • Proven ability to follow instructions/guidelines, work independently and on own initiative.
- • Excellent attention to detail and accuracy and maintain consistently high quality standards.
- • Excellent written and verbal communication and report writing skills.
- • Sound judgment; independent thinking and decision making skills.
- • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Bachelor's Degree or educational equivalent in a Scientific or Healthcare discipline and 2 to 3 years experience of drug safety or 3 years safety scientist coordinator or minimum 1 year experience in aggregate reporting or equivalent combination of education, training and experience.
* Quintiles helped develop or commercialize 98 of the Top 100
best-selling products of 2015
* Quintiles has 36,000
employees conducting business in more than 100
* Quintiles was named to FORTUNE's World's Most Admired Companies®
* Quintiles was named as a 2016 World's Most Ethical Company®
by the Ethisphere Institute