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| About us |
| We are a quality-driven contract research organization (CRO) serving the pharmaceutical industry and specializing in Drug Safety services... |
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| Our strengths |
| QSI is an organization specializing exclusively in Drug Safety. Our primary strength is Safety Operations... |
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| We are recruiting. If you wish to be considered for the following position(s), please write to us at hr@qsi.in quoting the relevant position code: |
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| Pharmacovigilance Scientist Position Code: DSA001 |
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| Chandigarh |
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| Manage activities relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational products in accordance with the applicable regulatory requirements. |
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| Minimum qualification(s): Master degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Medicine or Dentistry; experience in the Pharmacovigilance industry would be an advantage. 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 MS XP, Window 7professional operating system and the MS Office suite (Word / Excel / Power Point), 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, strong written and oral communications skills are required. |
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| Drug Safety Physician Position Code: DSP002 |
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| Chandigarh No. of Openings: 9 |
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| Responsibilities: Report preparation [e.g. Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events; Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans; Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues; Performing medical review of individual case safety reports (ICSRs); Performing medical review of narratives for Clinical Study Reports (CSRs); Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives; Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs); Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions; Maintaining records in compliance with guidelines and SOPs. |
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| Minimum qualification(s): A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch; Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position; Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text; Ability to evaluate and interpret data, draw conclusions independently and synthesize scientific data; Fluency in written and spoken English; Proficiency in computer skills in MS XP/Vista/Windows 7 Operating system and the MS office suite (2003/2007/2010 & Word/Excel/Power point) and an ability to work with web-based applications; Typing and transcription accuracy; Attention to detail. |
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