Assistant Manager - Pharmacovigilance
Job Description
- Medical assessment of the safety profile of the client's product range
- Responsibility for evaluation of Adverse Events
- Medical Review of aggregate reports
- Performing signal detection for clients medicinal product
- Preparation, evaluation and management of risk management plan.
Preparing Clinical Expert Statements as per client requirement
Literature review for selection of ICSR and article of interest (for signal detection and aggregate reports)
Provide guidance and participation in the follow-up of Adverse Events
Provide back-up medical support on products/projects where required
Knowledge of local and national requirements for Pharmacovigilance requirements.
Interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews.
Contributing to the on-going enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
Ensuring compliance with local regulations and Company global Pharmacovigilance requirements.
Providing medical inputs/replying any medical inquiry and to identify any potential AE in product quality complaint for all Lambda clients.
Assist in the development of appropriate Standard Operating Procedures and for the Department and clients.
Communication with clients and or regulatory agencies
- Responsibility for evaluation of Adverse Events
- Medical Review of aggregate reports
- Performing signal detection for clients medicinal product
- Preparation, evaluation and management of risk management plan.
Preparing Clinical Expert Statements as per client requirement
Literature review for selection of ICSR and article of interest (for signal detection and aggregate reports)
Provide guidance and participation in the follow-up of Adverse Events
Provide back-up medical support on products/projects where required
Knowledge of local and national requirements for Pharmacovigilance requirements.
Interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews.
Contributing to the on-going enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
Ensuring compliance with local regulations and Company global Pharmacovigilance requirements.
Providing medical inputs/replying any medical inquiry and to identify any potential AE in product quality complaint for all Lambda clients.
Assist in the development of appropriate Standard Operating Procedures and for the Department and clients.
Communication with clients and or regulatory agencies
SEND CV TO :- hr@lambda-cro.com
No comments:
Post a Comment
Note: only a member of this blog may post a comment.