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Post: H and LS Medical Writer
Job Description:
o Writing first draft of Aggregate Report (e.g. RMP, PVP, PSURs, PADERs, ASRs, QSUSARs)
o Literature Search
o Newly analyzed, ongoing and completed study information from, but not limited to, clinical, non-clinical, and epidemiology studies.
o Current Reference Safety Information (e.g., CCSI/CCDS/CPLP)
o Conduct analysis of singles cases extracted
o Ensure consistency with quality, accuracy, and medical safety standards
o Review and follow-up reports with relevant stakeholders internally (Lead TA, local market PV, Global Regulatory Teams, Medical Surveillance Team, Pharmaco-epidemiology, etc.)
-Attaches/ reviews all letters and queries for appropriateness and completeness.
-Oversees all the team resources in the work.
-Oversee execution of Quality Control and discrepancy management for outputs
-Assist in training for new resources and as a part of continuous improvement
-Assist in the development of documentation such as work instructions or task checklists for readiness activities as required
-Ensure compliance with client and company policies
-Own assist and comply to all SLAs (Cycle time and quality)
Requirements:
- No special physical demands.
- Major part of work done in office environment.
- High degree of accuracy and attention to detail.
- Good decision making ability.
- Demonstrated strong writing skills and has written publications.
- Ability to analyze, understand and interpret complex scientific data from a broad range of scientific disciplines.
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Candidate Profile
Ph.D. in Life Sciences or Pharmacy/M.D. in Pharmacology or Physiology or Human Genetics or Public Health
Additional Information:
Qualification: Ph.D. in Life Sciences or Pharmacy/M.D. in Pharmacology
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical reviewer
Job Number: J1740
End Date: 20th Feb., 2017
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