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| Job Location | Chandigarh |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Technical Writing |
| EmploymentType | Full-time |
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.QualificationsScience/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,
Keyskills :
pharmacovigilancesafetycdsemams office suitestandard operating proceduresms officedrug safetymusic makinglife sciencesquality checkrisk evaluationsafety statements