Safety Surveillance Scientist For Team Lead Role

Golden Opportunities Pvt Ltd

4 - 8 Years

Mumbai

Job Description

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

Role:
" To ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives"

policies

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"

indications

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

Education Qualifications:
B.Pharm M.Pharm PhD Life sciences Post-graduate

Email Address:nandhini@gojobs.biz