Major duties and responsibilities:
• oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, • maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, • leads or participates in cross-functional projects or initiatives within Global Pharmacovigilance collaborates with the GSO in the review of Clinical trial and post-marketing program documentation and on labeling activities, • establishes strong collaboration with cross-functional groups within and outside the company (i.e Business Partners, CRO), • is the SME during internal / partner audits and inspections
Skills and Education:
• MD or Physician
• 3 to 5 years of experience in healthcare-related field and/or patient-care activities desirable
• 3+ years of Pharmacovigilance experience or equivalent relevant pharmaceutical industry experience (clinical development, data management, etc….)
• Supervisory and mentoring experience highly desirable
• Thorough medical knowledge of the safety profile of assigned products
• Experience in pharmacovigilance databases
• Robust expertise with MedDRA coding
• Thorough knowledge of regulations (e.g. FDA, EMA…)
• Computer literacy, especially MS Office programs
• Able to communicate, verbally and in writing in a good and understandable English level
• Able to influence and establish strong collaborations with cross-functional groups within and outside the company
• Able to prioritize activities and demonstrate high quality of work, flexibility
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