*key responsibilities*:*case intake processing*:- receive, review, and triage incoming ae reports from various sources.- creating, maintaining, and tracking case folders; filing, retrieving and distribution of case folders to operations team members.- perform icsr surveillance on administrative topics and process including collection, reporting, follow-up processes.- accurately enter ae data into the company's safety database.- conduct initial case assessment and assign appropriate case status.- track and monitor the progress of ae investigations.- prepare case narratives and other relevant documentation.- assist with the preparation of safety reports for regulatory submissions.
*data management & quality control*:- ensure the accuracy and completeness of all ae data.- perform data entry and validation checks.- maintain accurate records and documentation.- support periodic audits and quality control checks on case processing activities.
*communication & collaboration*:- communicate effectively with internal and external stakeholders, including medical professionals, regulatory agencies, and other departments within the company.- collaborate with other team members to ensure timely and efficient case processing.- respond to inquiries and requests for information in a timely and professional manner.
*regulatory compliance*:- ensure compliance with all relevant regulatory requirements, including good pharmacovigilance practices (gvp) and local regulations.- stay informed of any changes to relevant regulations and guidelines.
*process improvement*:- identify and implement process improvements to enhance the efficiency and accuracy of ae intake processes.- participate in team meetings and contribute to the development of best practices.
*qualifications*:*education*: bachelor's degree in a life science field (e.g., biology, pharmacy, nursing) or equivalent experience.fluent local language skills & excellent command of the english language*experience*: 1 year of experience in pharmacovigilance or a related field preferred.
*skills*:- strong attention to detail and accuracy- excellent organizational and time-management skills- proficiency in microsoft office suite (word, excel, outlook)- strong written and verbal communication skills- ability to work independently and as part of a team- excellent problem-solving and analytical skills*preferred qualifications*:- experience with electronic data capture (edc) systems- knowledge of medical terminology and coding systems (e.g., meddra)- experience with regulatory submissionsli-remote