Parexel Drug Safety Associate – Pharma Candidates Apply
Drug Safety Vacancies Parexel – Pharma Apply. Drug Safety Associate Jobs – Parexel Hiring, Apply Online. Parexel Associate careers. M Pharma Job Opening 2020, Interested and eligible candidates may check out all the details like eligibility criteria, job description and how to apply below:
Job Title: Drug Safety Associate
Job ID 58752BR
Location: Chandigarh, Chandigarh, India
Qualifications
• Science/Medicine degree: The minimum qualification required would be a Masters degree in Pharmacy
• 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
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
• 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
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