Compilation and management of safety variations filed for ADVANZ PHARMA products at any time of product lifecycle.
Writing Clinical Evaluation reports as support document for the safety variation filling.
Writing responses for Regulatory Requests for Information (RFIs).
Provide inputs during quality review of safety packages as and when required.
Actively co-ordinates with all internal and external stake holders with members of medical Affairs, Regulatory affairs, and Quality departments towards processing all submissions to the competent authorities on time for ensuring pharmacovigilance and Regulatory compliance.
Ensuring compliance and quality in safety variations activity
Provide input into Quality System as required
Support the team in pre and post action arising from PV audits and inspections
Seek and deliver operational efficiencies across the Drug Safety, Medical Affairs and Regulatory Affairs teams
Keep abreast of changing PV regulations across the Globe.
Actively coordinate with all the internal and external stakeholders.
Participate in the generation of Standard Operating Procedures (SOP) for the same
• Ensure all documentation is structured and maintained as required
Providing annotated documents for variation fillings or update of SmPC and PIs.
Providing response to RFIs.
Providing feedback from quality review of safety packages
Compliance with GPvP requirements, demonstrated through audits and inspections.
Support to the business and provision of documentation within agreed timeframes.
Successful relationships with all external partners.
Address internal and external inspection findings.