Medical Writers
- Quiscon Biotech
- 0 to 1 Yr
- Multi-City, India
- 3 years ago
- Email to a friend
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Job Description
Medical Writers:
Job description
Roles and Responsibilities
Responsibilities
- 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
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Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech Role Category: Bio Tech / R&D / ScientistPharmacist / Medical Representative Functional Area: Not ApplicableRole/Responsibilies: Medical WritersContact Details:
Company: Quiscon BiotechLocation(s): Multi-City, India
Keyskills: clinical research associates clinical research clinical data management clinical monitoring clinical pharmacology clinical trials
Quiscon Biotech
Aviyana Ventures Pvt. Ltd. was incorporated in 2013 as RPG Ventures and became private limited in 2015. The company is passionate to provide employment to vast majority of prospective job seekers and assist companies in talent acquisition.
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