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Medical Writers - Pune

0.00 to 1.00 Years   Mumbai City   17 Aug, 2023
QUISCON BIOTECH
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 4.0 - 5 Lakh/Yr
IndustryPharma / Biotech
Functional AreaPharmacist / Medical RepresentativeBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Medical Writers:Job descriptionRoles and ResponsibilitiesResponsibilities
    • Responsible for the collection and monitoring of metrics and key performance indicators (KPIs) related to global pharmacovigilance compliance.
    • Responsible for co-ordinating with PV service provider(s) and ensure the vendor PV compliance
    • Collaborate on PV service provider specific SOPs, Work Instructions, etc. managing the process for the global PV related documents
    • Responsible for ensuring that quality and compliance activities are performed in accordance with policies, guidelines, current regulatory requirements, and other relevant standards both globally and regionally
    • Responsible for development of audit and inspection report responses CAPAs, tracking and monitoring, implementation of CAPAs associated with any PV.
    • Responsible for PV teams Audit/inspection readiness and participates in Audits/inspections
    • Responsible for updating and maintaining of the Quality Management Plans & Pharmacovigilance Safety Master File (PSMF)
    • Providing continuous insights to the PV team on Quality improvement initiative in line with the Global and Local regulatory authority requirement/updates
    • Working knowledge of PV regulations pertaining to the countries and regions specific pharmacovigilance requirements
    • Conducts quality review meetings as needed
    • Prepares end of line QA reports, identify performance trends, and opportunities for ongoing improvement, Compliance/Quality metric Dashboard, and workflow management, Regulatory authority tracking, Safety reporting tracking, reporting plans and executing changes as needed
    • Other duties as assigned
    Interested to apply can share CV to hidden_email or call/whatsapp to hidden_mobile.

Keyskills :
clinical monitoringclinical pharmacologyclinical trialsclinical data managementclinical research

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