Freshers may apply as Pharmacovigilance - Drug Safety Associate @ PAREXEL

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PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Post: Drug Safety Associate

Job Description:
Essential Function
The Drug Safety Associate will 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).

Key Accountabilities
- 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

Candidate Profile:
Education (one of:)
- 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

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