Job Opening for Drug Safety Specialist in Parexel

There are opening for Drug Safety Associate in Parexel International. The details are as follows :

Title              : Drug Safety Specialist

Location       : Hyderabad, Andhra Pradesh, India 

Department  : Pharmacovigilance

Qualification

• Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification 
• Associates/diploma degree in any of the above with appropriate work experience

Skills & Experience 

• Sound knowledge of drug safety and the drug development process 
• Knowledge of and ability to interpret and apply global safety regulations. 
• Experience in data analysis and evaluation of safety data
• Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations
• Good presentation skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Good time management skills
• Team player
• Client focused approach to work 
• Experience with computer applications including database management and pharmacovigilance related computing systems
• Drug safety knowledge and experience in Safety Database

 Job Profile

• Initial data entry of case reports into safety database / tracking system 
• Assessment of case reports for seriousness, causality and expectedness
• Requesting follow-up i.e. written, telephone
• Adverse event (AE) and drug coding
• Writing case narratives
• Create and maintain project specific working files, case report files and project central files
• Assist with additional Drug Safety Specialist activities as required
• Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects
• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
• collection and review of endpoint packages
• review and follow-up laboratory alerts
• review and follow-up patient eligibility for inclusion / exclusion in clinical trials
• review and follow-up protocol violations
• review study specific Model ICFs according ICH/GCP criteria
• Participate in client meetings / investigator meetings / project specific training sessions 
• Delegate work as appropriate to Drug Safety Assistants

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