Team Lead - Pharmacovigilance _ICSR and Aggregate reports

• Jun 2023 - Present

Senior Safety Specialist -Global Patient Safety

• Nov 2019 - Apr 2023

• Review of the scientific and medical literature in accordance with companies-controlled documents and guidelines.• To identifying ICSRs and other significant/potential safety information.• Assist to set search strategy in Data base (Ovid)• QC of the Spontaneous and literature Cases (ICSRs) processed in the Safety Database• Provide and track feedback of any observation to the individual who processed the ICSR.• Support for creation, improvement and maintenance of standardized departmental procedures Triage of cases received from different sources Spontaneous, Study-PSP & MRP, Regulatory reports (EV & MLM downloads) and prioritize for daily workflow management.• Completion of remaining case data entry (including narrative or auto-narrative), manual coding, causality assessment and labelling assessment• Keeping track of the Product/Device Quality Complaints • Interacting with internal or external contacts to resolve issues related to the processing of cases.• Provide training to outsource vendor for Literature review and case processing. This includes overseeing new hire training and certification and ongoing training and feedback for existing vendor staff. Show less

PV Associate- Global and local patient safety

• Mar 2018 - Oct 2019

• Respond to queries from country PV and/or Global PV and its service provider.• Process update (Handle SOP review and update)• Handling SDEA/PVA (PV Agreements) - Draft, negotiates and finalize the agreement.• Performing reconciliation - internally with MI/QA and with partners.• Provide training to the Partners and maintain tracking of all training • Informing management about any process error and drafting of process error.• Delivery of information for aggregate reports and other regulatory documents as requested.• Submit electronic (E2B) regulatory reports to applicable Regulatory Authorities• To prepare and verify Aggregate reports (PSUR/PADER) • To assist in responding to the regulatory queries.• To assist in preparation for the regulatory audits and responses to the audit queries. Show less

Senior Executive - Team lead

• May 2017 - Feb 2018

Executive

• Jan 2016 - Apr 2017

Clinical Research Associate

• Jul 2015 - Jan 2016

Monitoring of Clinical Trials (Phase II, III, IV & BA-BE studies) Monitoring of Clinical Trials (Phase II, III, IV & BA-BE studies)

Clinical Research Coordinator

• Nov 2013 - Jul 2015

Handling Clinical Trials (Phase II, III, IV & BA-BE studies) in different area like Psychiatric, Skin, General medicine and Surgical. Handling Clinical Trials (Phase II, III, IV & BA-BE studies) in different area like Psychiatric, Skin, General medicine and Surgical.

Assistant Professor

• Oct 2012 - Oct 2013

Lecturer

• Aug 2010 - Aug 2012

Clinical Research Coordinator

• Sep 2006 - Jun 2009

Conducted Global Phase I-IV Trails as a clinical research co-ordinator. Conducted Global Phase I-IV Trails as a clinical research co-ordinator.