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.
Post : Medical Writer II
Job Description
• 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
Candidate Profile
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
Additional Information
Qualification : University degree
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th May, 2021
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