IQVIA Pharmacovigilance Senior Safety Operations Specialist in Warsaw, Poland
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. Liaise closely with operations team manager to ensure proper distribution of daily workload amongst the team.
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
Ensure proper distribution of daily workload amongst the team members.
Provide regular feedback to operations team manager on project metrics, out of scope work challenges/issues to ensure the project timelines are met
Determine initial/update status of incoming events, code AE and Products, write 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.
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.
Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
100% compliance towards all people practices and processes
Bachelor's Degree in Healthcare or Life Science discipline
At least 3 years of relevant work experience, inclusive of up to 3 years of Pharmacovigilance experience
Excellent knowledge of medical terminology
Excellent written and verbal skills in English and French or German or Spanish or Italian
In depth knowledge and understanding of applicable Safety Database
Excellent organizational skills, time management skills, attention to detail and accuracy.
Excellent working knowledge of Microsoft Office and web-based applications.
Very good Time-management and leadership skills.
Excellent verbal/written communication skills.
Self-motivated, flexible, receptive to changing process demands.
Proven ability to work independently and autonomously with policies and practices.
Ability to identify, prioritize tasks and delegate to team members.
Demonstrate sound judgment and decision making skills.
Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities
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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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