Urgent Openings for Pharmacovigilence-pmo
2 weeks ago
Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports.
- Ensures effective functioning of all PV projects in compliance with client agreement, contract; and local and global regulatory guidelines.
- Track the audit and responses and reports audit status to management on regular bases in compliance with GVP.
- Holds responsibilities of executing actions of pharmacovigilance systems and quality systems Mitocon Policies.
- Co-ordinate and perform audit for cross-functional departments and support QA team.
- Regular Monitoring of department workload and alerts the Team Manager/Designee in case of any problems relating to internal staff workload that may affect the quality and deliverables being undertaken.
- Co-ordinate internal resources for accurate execution of projects and deliver results to meet the client expectations.
- Develop and drive the quality review/sampling of ICSRs, literature, signal team and aggregate reports as part of quality management system.
- Develops and implement PMO processes and policies, direct project management staff and works with other department leaders to define, prioritize, and develop projects and programmes.
- Ensures service measures are met in accordance with Service Level Agreement (SLA).
- Lead kick-off calls for on boarding projects and design master project plan.
- Lead the preparation of Standard Operating Procedures and processing conventions.
- Lead sessions during Health Authorities inspections and audits as Subjects Matter Expert and lead the development and implementation of Corrective and Preventive Actions (CAPA) to address the safety findings.
- Ability to learn scientific quality deliverables according to established directives consistent demonstration of company values/behaviours.
**Salary**: ₹1,000,000.00 - ₹1,500,000.00 per year
**Benefits**:
- Health insurance
Schedule:
- Rotational shift
**Experience**:
- total work: 1 year (preferred)
Ability to Commute:
- Prakash Nagar, Hyderabad, Telangana (required)
Ability to Relocate:
- Prakash Nagar, Hyderabad, Telangana: Relocate before starting work (required)
Work Location: In person
**Speak with the employer**
+91 91543 83165
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