Roles and responsibilities
We have an immediate opening in one of the Best MNCs in India for the Role of Safety Surveillance Specialist for Mumbai Location
having the largest process for pharmacovigilance in India
Working Timings: Candidates should be flexible working in a 24*7 environment
Level: Team Lead
" To ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives"
procedures and processes.
" To assist physician in maintaining up to date knowledge of the firm products assigned with focus on the safety perspective. "
" This includes but is not limited to pharmacology"
safety and efficacy aspects and could potentially include clinical studies and epidemiological analyses.
" To review Companies surveillance strategy document and provide written confirmation verifying its understanding of changes."
" To review aggregate case reports from clients designated safety database using relevant IS systems."
" To identify safety signals from routine review of cumulative safety data and conduct initial evaluation of those signals and document outcome according to clients specified criteria and requirements."
" To document potential signal and related information in the signal tracking tool and maintain surveillance action log up to date."
" To conduct further evaluation of safety signal as required by firm"
using clients safety designated database and or the published literature
Required Candidate profile
Experience & Skills Required:
Minimum 4 years of experience in Safety Surveillance with Pharmacovigilance
Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions with client.
Ability to evaluate
Good working knowledge of safety database
Sound understanding of the Drug Safety and Regulatory process
Excellent interpersonal and communication skills
B.Pharm M.Pharm PhD Life sciences Post-graduate