Urgent Openings for Pharmacovigilence-pmo

5 days ago

Prakash Nagar Hyderabad Telangana, India Mitocon Biopharma Pvt Ltd Full time

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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