PAREXEL International
For
over 25 years 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.
we
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. We 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. For more information about
PAREXEL International visit www.PAREXEL.com.
Current Vacancy:
- Post: Drug Safety Associate- Department Worldwide Medical Services
- SBU Clinical Research Services (CRS)
- Department: Pharmacovigilance
- Location: AS - India - Hyderabad
- Employment Type: Full Time
- Job Type: Regular
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
Language Skills: Fluent English
Experience: Related experience gained in Pharmacovigilance or a healthcare environment
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).
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).
Relationships
- Reports To Regional Head of PV Operations/Team Manager PV Operations
- Directly Supervises None
- 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
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
Skills
- Clear 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 computer applications including database management
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