Drug Safety Associate require at PAREXEL | M.Pharm, M.Sc
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: Drug Safety Associate.
Job Description
• 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.
• 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 the processing of the reports
• 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 the processing of the reports
Candidate Profile
• 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, and 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.
Additional Information
Qualification: M.Pharm, M.ScLocation: Chandigarh
Industry Type : Pharma / Healthcare / Clinical research
Functional Area: Drug Safety
End Date: 15th March 2020
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