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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BDGeneral / Other Software |
| EmploymentType | Full-time |
JOB LOCATION:- GLOBAL R&D ( VIKHROLI), Mumbai Job Summary: 1. Performs and provides peer review for the global pharmacovigilance processes: Signal detection, Risk management plans on products developed and manufactured by the company, with selective focus on the monoclonal antibody portfolio and literature review. Prepares/ reviews periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline. Job Responsibilities: Prepares and conducts peer review of periodic safety update reports (PSURs/PBRERs/PADERs ) for regulatory submission. Conducts literature reviews and provides assessment and analysis of published literature. Maintains current awareness of safety issues on company products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis and interpretation of safety data. Assists in the preparation/review of Risk Management plans. Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data. Liaises regularly and develops strong working relationship with external partners and international Company affiliates and demonstrates corporate values in the performance of work and in all interactions with others. Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology. Interacts with other internal departments when necessary. Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies. Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Group Leader and management to enhance knowledge. Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned. ,
Keyskills :
riskmanagementplansdrugsafetyriskmanagementcustomerservicesafetyregulationsliteraturereviewssignaldetectionichriskargussoundertmslobalrdregulatycomplianceregulatyguidelinesacle