Job title: SPVG Scientific Spec I – (DD)
Company: inVentiv Health Clinical SRE, LLC
Job description: Job Description : SPVG Scientific Specialist I Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work
Job Description : SPVG Scientific Specialist I Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors. Why Syneos Health . #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference. . We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial. . We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job responsibilities . Assists with safety and pharmacovigilance activities including (but not limited to) literature screening and review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, case processing or review of individual case safety reports, authoring or review of aggregate reports and ongoing safety evaluation activities. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information. . Maintains safety tracking for assigned activities . Fosters constructive and professional working relationships with all project team members, internal and external . Participates in audits as required/appropriate . Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities . Files documents according to project specific requirements (electronically or in hard copy as applicable) . Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities . Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Program Specific FIle or Pharmacovigilance System Master File for post-marketing programs as appropriate . Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, the drug development process and GVP Qualifications Qualification: M. Pharmacy, life science equivalent degree Minimum 2+ years of experience in Pharmacovigilance and ICSR case processing ICSR case processing (or data entry / quality review of ICSRs), MedDRA coding, drug coding, narrative writing Experience of working on safety database like Argus, ARISg, Eudravigilance Good understanding of clinical development processes including principles of clinical study operations, GVP and ICH-GCP guidelines Data entry of Individual case safety reports (ICSRs) which includes identification of suspect, events and narrative writing Coding of medical history, events, indications and laboratory tests using latest version of MedDRA Coding of suspect products and concomitant drug using company drug dictionary and WHO-DD respectively Processing of ICSRs from various sources like literature, spontaneous and clinical trials Search and identify duplicate ICSRs in the database and creation of Master case for underlying duplicate ICSRs/Cases in database
Expected salary:
Location: Hyderabad, Telangana
Job date: Thu, 03 Feb 2022 23:26:02 GMT
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