• Involvement in end-to-end pharmacovigilance activities of the client's product range• Quality review of ICSRs and Preparation of aggregate reports (PSUR, PBRER, PADER, Addendum to Clinical Overview etc.)• Literature review for selection of ICSR and article of interest (for aggregate reports and signal detection).• MedDRA upgradation and impact assessment• Contribute towards enhancement of Pharmacovigilance processes and writing SOP/WI/Guidance documentsKey competencies: Process Expertise Experience in managing operations and offshore delivery Experience in managing performance Experience in transitioning processes Strong people management and leadership skills Excellent oral and written communication skills Focus on quality Ability to work across various domains Planning & Prioritizing Proactive risk identification and management Ability to engage the client and provide satisfactory responses to the client Coaching and mentoring skills

Roles and responsibilities:Monitored workload and allocates resources appropriately. Coordinate with the team to ensure that incoming AE reports are processed according to internal timeframes to meet client’s and health authority’s requirements.• Provided pharmacovigilance system related quality and compliance training and monitor continuous improvements in associates.• Periodic Benefit Risk Evaluation Report (PBRER), Periodic Safety Update Report (PSUR) and abbreviated PSUR (Ab PSUR), Addendum to Clinical Overview (Ad CO), Addendum Report, Summary Bridging Report (SBR) and Periodic Adverse Drug Experience Report (PADER).• Prepare and co-ordinate the team for client, global and regulatory authority, pharmacovigilance audits to ensure no critical observation in the projects.• Assist with clients and medical project managers for preparatory activities including strategies and metrics preparation, SOPs and Projects/work manual preparation for proposed projects.• Provide input into responses to inquiries from regulatory authorities, clients/licensing partners and healthcare professionals on safety issues.Preliminary Activity and Report Draft Preparatory Activity (Lead author)• Generation and review of LL and ST from safety database• Selection of relevant *literature articles for inclusion in report• Verification of data sources for any inappropriateness, discrepancy or missing data• Obtaining POC approval of LL and ST and ensuring necessary case correction (as appropriate),• Obtaining confirmation of selected literature articles and any clarification on data sources (as appropriate)• Assimilation of all data sources for draft preparation, including full text of selected literature as appropriate• Obtaining medical inputs and critical analysis on certain sections of the report from assigned medical reviewer• Preparation of draft for internal review*Intimation to literature review team to provide literature search results (TL or lead author).

Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in Drug Safety tracking tool and/or safety database.• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality.• Evaluate and finish processing of non-expeditable AE reports, including review of completeness and accuracy.• Use medical dictionaries and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.• Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed• Alert manager to potential safety signals based on incoming case reports

Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in Drug Safety tracking tool and/or safety database.• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality.• Evaluate and finish processing of non-expeditable AE reports, including review of completeness and accuracy.• Use medical dictionaries and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.• Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed• Alert manager to potential safety signals based on incoming case reports