opening for Drug Safety Specialist @ APCER Life Sciences - New Delhi Area, India
Job description
Medical Review of safety data in ARISg for purpose of expedited/periodic reporting.
Medical Review of Periodic Safety Update Reports as per Regulations and SOPs
Signal Detection and evaluation
Responding to Medical Queries (spontaneous/ regulatory)
Generation, review and execution of SOPs and Work Practice Guidelines
Compliance management with SOPs and regulatory requirements
Trains and mentors employees in pharmacovigilance
Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities and communicate new/changed regulations to management and to relevant members of the department in order to initiate any change in processes
Liaise effectively and maintain excellent relationship with clients and internal/external contacts and builds and maintains good relationships across functional units and company affiliates
Perform other duties required for the job as desired by management
Desired Skills and Experience
Graduate/Post graduate Degree in Medicine (MBBS/MD) from a MCI recognized institute mandatory
Exp- 0-2 Years
Knowledge of pharmacovigilance regulatory requirements
Good time management, presentation and communication skills
Ability to prioritize and plan projects and work effectively
Click here to apply
Job description
Medical Review of safety data in ARISg for purpose of expedited/periodic reporting.
Medical Review of Periodic Safety Update Reports as per Regulations and SOPs
Signal Detection and evaluation
Responding to Medical Queries (spontaneous/ regulatory)
Generation, review and execution of SOPs and Work Practice Guidelines
Compliance management with SOPs and regulatory requirements
Trains and mentors employees in pharmacovigilance
Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities and communicate new/changed regulations to management and to relevant members of the department in order to initiate any change in processes
Liaise effectively and maintain excellent relationship with clients and internal/external contacts and builds and maintains good relationships across functional units and company affiliates
Perform other duties required for the job as desired by management
Desired Skills and Experience
Graduate/Post graduate Degree in Medicine (MBBS/MD) from a MCI recognized institute mandatory
Exp- 0-2 Years
Knowledge of pharmacovigilance regulatory requirements
Good time management, presentation and communication skills
Ability to prioritize and plan projects and work effectively
Click here to apply
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