PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Drug Safety Specialist (Medical Affairs)
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 inspections
- Delegate 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
Candidate Profile
Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience ; Associates degree in any of the above with appropriate work experience in Pharmacovigilance.
Additional Information:
Location: Telangana - Hyderabad
Functional Area: Medical Affairs
Requisition: 41980BR
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 15th March, 2018
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