Asst. Manager-QA (PV)
0 - 5 Years of Experience
Not disclosed 
Full TimeAbryl Laboratories
Dera Bassi, Punjab, India
Posted on 24-12-2024
55 Views
1 Vacancy
Description
- Assist in the development, implementation, and maintenance of the pharmacovigilance (PV) system in compliance with regulatory requirements.
- Ensure that the PV system adheres to the highest quality standards and regulatory requirements for drug safety and adverse event reporting.
- Support the management of safety data, including adverse event (AE) reports, and ensure compliance with reporting timelines.
- Conduct quality audits of pharmacovigilance processes, systems, and data.
- Review adverse event (AE) case reports to ensure that they are accurately documented, classified, and reported in line with regulatory standards.
- Monitor the quality of PV activities and identify areas for process improvements, ensuring alignment with internal SOPs and regulatory guidelines.
- Provide guidance and training to the PV team on regulatory requirements, standard operating procedures (SOPs), and quality assurance processes.
- Ensure that all team members understand the importance of pharmacovigilance compliance and quality management within their roles.
- Coordinate or assist in training sessions for new employees or updated PV procedures and systems.
Category
Pharmaceuticals
Functional Area
Pharma Quality Assurance (QA)
Key Skills
Attention to DetailProblem solvingCommunicationTeam Work
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