Case Processing / Aggregate Report Writer

Role & responsibilities

Aggregate Reports

• Collection of safety data and Preparation of Risk Management Plan (RMP) PBRERs/PSURs, PADERs, Addendum to Clinical overview summary report, as per procedure outlined in SOP and guidelines
• Interact with team at various levels and in various functional areas to discuss and resolve any issues that arise during review of safety data and preparation of aggregate reports
• Responsible for timely submission of aggregate reports in order to achieve 100% regulatory compliance.

Literature Search & Review

• Creating an account and set search strategies on relevant literature database.
• To perform initial review of literature articles, retrospective reviews, local literatures, Safety Data exchange reports, digital media and segregating them into ICSRs, AOIs, on hold and not selected based on information provided in the article.

Triaging & Case Processing, Quality Check

• Case receipt and tracking, Triaging of ICSRs & Perform duplicate search.
• To review the quality of the ICSR against the source document and to check whether ICSR is processed as per the applicable SOPs

Medical Enquiry

• Handling of MICC activities
• Handle medical, pharmaceutical, and technical enquiries, including adverse events (AE)
• Ensure that enquiry is responded within defined timelines
• Receipt and reply to enquiries
• Maintenance and documentation of received enquiries • Reporting of AE to the case processing team.

Submission of ICSR

To confirm the case qualifies for expediting and the regulatory authorities where case is to be expedited.

• Electronic or non-electronic reporting of ICSRs and additional safety information, to regulatory authorities in accordance with the procedure mentioned in SOP.
• To ensure that all ICSRs have been submitted or locked as per procedure outlined in SOP

Additional Responsibilities

• Assisting team in preparation for internal or external audits.
• Maintain a working knowledge of GCP, GVP and SOPs and applicable regulatory guidance
• Perform additional adhoc activity as assigned by the management for timely completion as per required by client or sponsor.
• Support QPPV/PvOI/LRP for Development and maintenance, including review and sign off new and existing client PSMF, PvMF, PSS and SPS as required.
• Preparation, revision, review of SOPs, templates and guidance training documents
• Communication of urgent safety issues to HOD and QPPV/PvOI
• Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company global Pharmacovigilance requirements
• Deliver training to new joinee and team as per requirement.
• Acts as a Single Point of Contact (SPOC) for client Others
• Any other additional responsibility assigned by the Reporting manager/ Designee

Others

• Any other additional responsibility assigned by the Reporting manager/ Designee.