Your talent, our mission. Join Navatio Pharma! Navatio is hiring for Pharmacovigilance Quality Assurance / Sr. Pharmacovigilance Quality Assurance role.
Job Description
Management of SOPs and Document Control:
- Quality assurance support and expert advice to operational pharmacovigilance (PV) services activities to ensure compliance with applicable regulatory requirements and procedures and quality standards.
- Support maintenance of the Pharmacovigilance System Master File (PSMF).
- Ensure that all pharmacovigilance activities are covered by appropriate SOPs, work instructions, and guides, which fully explain the processes.
- Monitor and manage the quality of documents produced by the department, including the ICSRS, Aggregate reports, and SOPs, to meet both internal SOP standards and external regulatory standards.
- Drive a culture of quality by close business partnering to positively impact the business.
- Timely review and feedback on policies, guidelines, and procedures.
Training:
- Training on the use and revision of PV SOP’s.
- Design, Implement, and coordinate the training on SOP’s.
- Lead the development, implementation, and conduct of appropriate training.
Inspection/Audit Management:
- Effective coordination, facilitation, and follow-up of HA inspections, successful management of the PV-related actions of the PV/RA Quality Plan timely escalation through proper channels of issues and findings that impact PV.
- To Support QPPV on Internal/external/vendor or client Audit.
- Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify specific PV, regulatory, compliance and QA training needs for business partners.
Eligibility Criteria
- B Pharm and M Pharm in Quality Assurance or experienced and qualified in a healthcare profession.
- Excellent working knowledge of US/EU Pharmacovigilance.
- Able to work independently and as part of a team.
- Excellent written skills.
- Proficient in MS Office.
How to Apply?
To apply for the position of Pharmacovigilance Quality Assurance / Sr. Pharmacovigilance Quality Assurance at Navatio Pharma Solutions Pvt. Ltd., please submit your resume to the email ID provided below.
hr@navatiopharma.com
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