Opening for the Post of Drug Safety Associate at Parexel || Life Science Candidates Eligible for Freshers @ Hyderabad "D"

ob Title: Drug Safety Associate

No. of Openings: 1

Job Description:

• Provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
• Report To Regional Head of PV Operations/ Associate Team Manager PV Operations
• Provides Work Direction to Drug Safety Assistants
• Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
• External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives
• Triage of incoming reports for completeness, legibility and validity
• 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

1. Qualification: B.Sc./M.Sc. Life Science
2. Experience: 1-2 years

Desired Skills:

• Understanding of drug safety and the drug development process
• Analytical and problem solving skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Time management skills
• Team player

• Client focused approach to work
• Experience with basic computer applications
• Fluent English
• Related experience gained in Pharmacovigilance or a healthcare environment

Location: Hyderabad

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