Establish and maintain a robust local pharmacovigilance system tailored to distributor operations and regulatory requirements.
Efficient collection, assessment, and reporting of adverse events from distributed products, ensuring timely compliance with local and global regulations.
Ongoing monitoring of local and international literature for safety signals and regulatory intelligence relevant to distributed products.
Direct support for communication with health authorities, including preparation for audits, inspections, and regulatory queries.
Preparation and maintenance of all required PV documentation, including SOPs, agreements, and compliance records for distributors.
Proactive identification and management of safety signals, with tailored risk minimization strategies for distributed products.
Round-the-clock support for urgent PV issues, adverse event intake, and distributor queries.
Expert guidance to ensure distributor PV systems meet all local and international regulatory requirements, including EMA, FDA, and CDSCO.