High Salary PHARMACOVIGILANCE

4 weeks ago


Hyderabad, India Hetero Labs Limited Full time

Job Description - Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance. - Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures. - Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission - To develop and review pharmacovigilance SOPs. - Coordination with MICC for ICSR activities and regulatory compliance. - Coordinating the safety data exchange agreements between Hetero and business partners. - Responsible for providing guidance and training to team as and when required. - Responsible for identifying, implementation and continuous improvement activities. - Responsible to handle audits and inspections



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