GVP Auditor 10

Profile: An astute professional with experience of over 12 years including Pharmacovigilance, quality and Training/compliance, Regulatory affairs and submission, ICH-GCP aspects, literature monitoring, Clinical Data management, GVP audits, ICH-GCP, MedDRA, RDC Studies, good pharmacovigilance practices (GVP), have hands on proficiency and skills on software’s like MedDRA, RDC studies, Oracle clinical (OC), ARISg, Empira Trace, Argus safety databases. Wide experiences in support to Pharmacovigilance Compliance projects. To report spontaneous ICSRs to Health Authority. To perform ICSR reconciliation with business partners. Receive, follow-up and report adverse events. To assist with Pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews as required. To review literature screening search results, identifying ICSRs and other safety-related findings. Clinical Trials. Creation and update of Pharmacovigilance Master Files, SOPs, PSURs and other periodic reports. ICSRs’ management. Signal detection and management. Pharmacovigilance System Master File (PSMF). Support in the preparation and revision of Risk Management Plans. Pharmacovigilance Systems and their Quality System. Pharmacovigilance Audits. Collection, management and submission of reports of suspected adverse reactions to medicinal products. Creation and update of local PV files. Handling ICSRs: Filling and sending the forms, follow up, submission to HAs, and. Archiving and completion of monthly compliance reports. Preparing, conducting and documenting PV training. Clinical research. Reviewing protocols and Case Report forms (CRFs) for planned local trials and submitting for approval, conduct and monitor Clinical trials. Actively participated in conducting GCP workshops. Establish and Maintenance of PV Systems. Global and Local Literature Search. Reporting (ICSR, PSUR and other aggregate reports). RMP and Signal Detection. Safety communication with Health Authorities. Dear Healthcare, Professional Communications (DHPC). Wide experience in Process Management. Location Preference: PAN India. Based in Pune. Have experience in PV audits in all European and Asian countries.