Assistant Program Management Manager
1 week ago
Role & responsibilities:
- Help guide the project team members in reporting adverse events
- Should have good knowledge of regulatory guidelines.
- Ensure Adverse event SOP compliance
- Ensure all the program team members are trained on adverse events as per Novartis guidelines
- Ensure time-to-time the updates received from Novartis with respect to adverse event reporting etc. are communicated to the respective team members
- Ensure to perform and complete the adverse event reconciliation as per Novartis guidelines
- Help perform & ensure the source data verification is completed on an annual basis as per Novartis guidelines
- Ensure to maintain the adverse event reconciliation is completed as per the Novartis guidelines and timelines
- Ensure all the monthly KPIs are met, and the reports are shared with the respective program managers in a accurate and timely manner
- Conduct initial or planned trainings/need based trainings for product information or adverse event reporting as per the Novartis guidelines
Preferred candidate profile:
- Graduate (preferably B.Pharma/Biology) with 3-5 yrs experience
- Application and knowledge of departmental processes and guideline
- Team management & coordination with internal and external stakeholders
- Ability to work in a process-driven/structured environment.
- Good computer skills MS Office (basic knowledge of MS Excel)
- Strong ability to provide support in project/program delivery
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