Parexel
International Corporation Drug Safety Associate Medical Sciences Opportunities
at Parexel Masters degree in Life Sciences Pharmacy, Microbiology,
Biochemistry, Biotechnology, Biophysics etc
Preparing
PSRs including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk
Evaluation Reports (PBRERs), Pharmacovigilance (PV) contributions to
Development Safety Update Report (DSUR), Periodic Adverse Drug Experience
Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum
Reports, Safety Statements and Semi-Annual Safety Reports (SASRs) and checking
of International Non-proprietary Names (INNs) for inclusion in a PSR in
accordance with client requirements/conventions and Standard Operating
Procedures (SOPs)
• Performing
quality check of PSRs as per client requirements
• 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
• Interacting
with internal or external contacts to resolve issues related to the processing
of PSRs
• Sending
queries to and liaising with the relevant client personnel regarding
discrepancies, for obtaining incomplete/missing information with a view to
resolve and clarify issues and facilitate processing of the reports
Qualifications
•
Science/Medicine degree: The minimum qualification required would be a Masters
degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology,
Biophysics etc.)
• Good
knowledge of medical terminology
• Fluency in
written and spoken English
• Computer
proficiency, an ability to work with web-based applications, and familiarity
with the Windows Operating System and the MS Office suite (MS
Word/Excel/PowerPoint)
• Capability
to make concise, accurate and relevant synopses of medical text and data, and
the ability to write unambiguous medical text
• Ability to
evaluate data and draw conclusions independently
• Typing and
transcription accuracy
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