Job Overview
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.
Key Responsibilities
Process and manage safety cases, including adverse event intake, data entry, coding, narrative writing, quality review, and case follow-up activities.
Assess case reportability and support regulatory submissions within required timelines.
Perform pharmacovigilance activities in accordance with SOPs, regulatory requirements, and project-specific guidelines.
Support activities across Safety services, including Safety Surveillance, Risk Management, Safety Publishing, and Medical Information where applicable.
Maintain high standards of quality, compliance, productivity, and delivery.
Provide training, mentoring, and day-to-day support to less experienced team members.
Monitor project progress, metrics, and operational performance, escalating issues when needed.
Collaborate with project management, clinical, data management, investigators, and clients to resolve project-related issues.
Contribute to process improvements, training initiatives, and departmental goals.
Participate in audits, inspections, and continuous improvement activities as required.
Depending on project requirements, perform medical review of non-serious adverse events and ensure data quality, completeness, and regulatory compliance.
Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related scientific discipline.
Up to 5 years of relevant experience, including up to 3 years of Pharmacovigilance experience.
Strong understanding of pharmacovigilance processes, case management, and safety regulations.
Excellent knowledge of medical terminology and safety databases.
Strong organizational, time-management, and problem-solving skills.
Excellent written and verbal communication skills.
Ability to manage multiple priorities while maintaining high levels of accuracy and quality.
Proven ability to work independently and collaboratively in a fast-paced environment.
Strong mentoring, stakeholder management, and relationship-building skills.
Proficiency with Microsoft Office and web-based applications.
Experience with global pharmacovigilance regulations and industry standards.
Experience supporting audits, inspections, and process improvement initiatives.
Project coordination or leadership experience within a safety operations environment.
Flexibility to work across global teams, different time zones, and shift schedules as required.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.