IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines.
Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE) / endpoint informationdetermining initial / update status of incoming events database entry
Perform activities related to adjudication as applicable
Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project.
Liaise with relevant stakeholders to facilitate expedited reporting.
Liaise with manager for regulatory tracking requirements and electronic reporting.
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Ensure to meet quality, productivity and delivery standards per project requirements.
Ensure compliance to all project related processes and activities.
Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
Typically requires 2 - 3 years of prior relevant experience.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.