Medical Writer I/II

• 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

QualificationsScience/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