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
Keyskills:
Desired Profile
Education:UG -MBBS - Medicine
PG - M.S/M.D - Other
Doctorate - Doctorate Not Required
Company Profile
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad - India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA. Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our comprehensive services are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly.
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