Senior Safety Scientist
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Centre deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
- Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.
- Lead, author and finalize aggregate reports, including but not limited to PBRERs, DSURs, PADERs, RMPs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required.
- Conduct/Lead 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.
- Conduct/Lead 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, acknowledge and adhere to all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
- Serve as the interface between the global project lead and the working team; conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
- Provide mentorship and training to less experienced resources.
- Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner.
- Excellent knowledge of Lifecycle Safety services and processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
- In depth knowledge and 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, 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 maintaining consistently high quality standards.
- Excellent written/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.
- Effective mentoring and coaching skills.
- Good understanding of operational metrics, productivity and initiatives.
- Demonstrate effective project management and leadership skills.
- Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and 3-4 years’ of drug safety or 2 years’ experience in aggregate reporting or equivalent combination of education, training and experience.