Medical Writer I/ii Job in Parexel International Corporation
Medical Writer I/ii
Parexel International Corporation
4+ weeks ago
- Chandigarh, Chandigarh
- Not Disclosed
- Full-time
Job Summary
Preparing end to end PSURs (including ad-hoc requests) in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)
Liaising with the relevant stakeholders regarding discrepancies, and for obtaining incomplete/missing information (where required), in order to resolve and clarify issues and to facilitate processing of the reports
Maintaining excellent knowledge of the safety profile of the assigned products, client s procedures and international drug safety regulations
Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with timelines communicated by the client
Performing self QC of reports
Ensuring MedRDA coding in accordance with MedRDA Term Selection: points to consider where applicable
A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage Apply Now Save Job
Responsibilities
Preparing end to end PSURs (including ad-hoc requests) in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)
Liaising with the relevant stakeholders regarding discrepancies, and for obtaining incomplete/missing information (where required), in order to resolve and clarify issues and to facilitate processing of the reports
Maintaining excellent knowledge of the safety profile of the assigned products, client s procedures and international drug safety regulations
Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with timelines communicated by the client
Performing self QC of reports
Ensuring MedRDA coding in accordance with MedRDA Term Selection: points to consider where applicable
Qualifications
Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences (PhD., Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage Apply Now Save Job
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