Senior Medical Information Specialist (French/Spanish/Italian)
- Experience Level
- Experienced (non-manager)
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
• Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information
• Determining initial/update status of incoming events
• Coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
• 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
• Set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
• Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes
• Provides effective feedback on project performance to junior members of team
• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts.
• Participate or Lead trainings across Safety process service offerings
• Address project related issues to health care professionals e.g. investigators, medical monitors, site coordinators and designees
• Liaise with client in relation to details on day to day activities as needed.
• Bachelor's degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience
• Excellent knowledge of medical terminology
• Excellent written and verbal skills in English and Spanish/Italian or French
• Proven experience in providing trainings will be an asset
• Knowledge and understanding of applicable Safety Database
• Understanding of applicable global, regional, local clinical research regulatory requirements
• Excellent organizational skills, time management skills, attention to detail and accuracy
• Excellent working knowledge of Microsoft Office and web-based applications
• To demonstrate effective project management and leadership skills
• Effective mentoring and coaching skills
• Ability to identify, prioritize tasks and delegate to team members
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.