Parexel Hiring Pharma Candidates For Drug Safety Associate Post

yle="text-align: center;">Parexel Hiring Pharma Candidates For Drug Safety Associate Post

Pharma jobs 2019. Durg Safety Officer Post vacancy at Parexel. Pharma jobs. Job opening for Pharma candidates for the post of Drug Safety Associate Post. Eligible & interested candidates are invited for the following purely temporary positions of Drug Safety Associate at Parexel. Candidates having Bachelors degree in Pharma may apply for this post online.Check out all the details on the same below:

Job Title: Drug Safety Associate

Job Id: 51603BR

Work Location: Hyderabad, Telangana, India

Eligibility: Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience

Desirable: Associates degree in any of the above with appropriate work experience in Pharmacovigilance.

Job Description:

• Assist in development of project specific safety procedures, workflows and templates
• Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
• Triage incoming reports for completeness, legibility and validity
• Electronic documentation and quality control of drug safety information
• Data entry of case reports into safety database / tracking system
• Request follow-up and perform query management
• Coding of data in the safety database
• Writing case narratives
• Create and maintain project specific working files, case report files and project central files
• Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required
• Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) or Project
• Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
• Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
• Participate in client and investigator meetings as required
• Attend internal, drug safety and project specific training sessions
• Perform literature searches
• Preparation for, participation in, and follow up on audits and inspectionsDelegate work as
• appropriate to Drug Safety Assistants
• Assistance in development of Expedited Reporting Procedures
• Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
• Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
  Submission of safety reports to investigators via ISIS (International Safety Information System)
• Assist with measuring investigative site performance in conducting required tasks in ISIS
• Tracking and filing of submission cases as required
• Assist with unblinding of SUSARs, as required
• Support collection and review of metrics for measuring reporting compliance\
• Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements

Apply Online

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