Pharmacovigilance Specialist/Xevmpd

Job Overview:

We are seeking a highly skilled and detail-oriented Pharmacovigilance (PV) Specialist to join our team. This individual will play a crucial role in ensuring the accuracy, compliance, and quality of our pharmacovigilance documentation, including Pharmacovigilance System Master File (PSMF) authoring, aggregate report writing, XEVMPD filings and ICSR Downloads.

Experience: 3 to 6 years

Key Responsibilities:

• Pharmacovigilance System Master File (PSMF) Authoring:
• Develop, review, and maintain the PSMF, ensuring compliance with relevant pharmacovigilance regulations.
• Work with relevant departments to gather the necessary information and documentation for PSMF creation and updates.
• Maintain and update PSMF in accordance with regulatory requirements and best practices.
• Ensure the PSMF is aligned with the companys pharmacovigilance system and global standards.
• XEVMPD Filings:
• Ensure accurate and timely submission of Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) filings.
• Collaborate with regulatory and safety teams to ensure that all medicinal product information is accurately reflected in the XEVMPD.
• Monitor regulatory updates related to XEVMPD requirements and ensure compliance with evolving guidelines.
• Aggregate Report Writing:
• Prepare and review of Periodic Safety Update Reports (PSURs) and PADERs,
• Analyse safety data and present findings in a clear, comprehensive, and accurate manner.
• Assist with signal detection and risk assessment processes through the interpretation of aggregate data.
• ICSR Download & Data Management:
• Download and manage ICSR data from the EMA and MHRA databases.
• Ensure that all relevant ICSRs are downloaded and shared with ICSR team.
• Perform initial data review to confirm completeness and consistency of ICSR information received from EMA and MHRA.