Drug Safety Life Science Job – Apply Online @ Parexel
Life Sciences candidates are requested to apply for a Drug Safety Associate position at Parexel. Parexel is hiring life sciences for a Drug Safety Associate position. Parexel Associate careers. Parexel has job openings for life sciences candidates. Check out all of the details on the same below:
Designation: Drug Safety Associate
Requisition ID: 56022BR
Location: Hyderabad, Telangana, India
- Assist in the development of project-specific safety procedures, workflows as well as templates
- Help in project-specific safety database setup, development of data entry standards, as well as user acceptance testing
- Triage incoming reports for completeness, legibility and also the validity.
- Electronic documentation as well as quality control of drug safety info
- Data entry of case reports into safety database/ tracking system
- Request follow-up as well as perform query management
- Coding of data in the safety database
- Writing case narratives
- Create and also maintain project-specific working files, case report files and also project central files
- Aid with extra Drug Safety Specialist on activities as needed
- Inform Line Manager (LM)/ Team Manager, Safety Services Project Leader (SSPL) or
- Project Leader (PL) and also Regional Head of PV Operations of potential change-in-scope of projects
- Support of Medical Directors/Safety Physicians, as required, in medical monitoring activities
- Participate in the client as well as investigator meetings as needed
- Participate in internal, drug safety as well as project-specific training sessions
- Perform literary works searches
- Preparation for, participation in, and also follow up on audits and inspections
- Delegate work as appropriate to Drug Safety Assistants
- Assistance in development of Expedited Reporting Procedures
- Assistance with registration with appropriate authorities for electronic reporting on behalf of the sponsor
- Assistance with establishing and deployment of around the world reporting as required to regulatory authorities, CECs, local ECs, as well as investigator sites (electronic and hard copy).
- Submission of safety reports to investigators via ISIS (International Safety Information System).
- Aid with measuring investigative site performance in conducting required tasks in ISIS.
- Tracking and also filing of submission cases as required.
- Help with unblinding of SUSARs, as required.
- Support collection and also the review of metrics for measuring reporting compliance.
- Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements.
- Degree in Pharmacy, Nursing, Life Science or other health-related fields, or equal qualification/work experience.
- Associates degree in any of the above with appropriate work experience.
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