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- Associate Medical Writer I
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Associate Medical Writer I
Parexel International Corporation
Mohāli, Punjab, India
• 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
Life Sciences/Medicine degree:
Bachelors degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
Masters degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.), Bachelors/Masters in dental surgery, PhD.
Job posted: 2020-11-13