Safety & PV Specialist I - Mexico Remote

Safety & PV Specialist I - Mexico Remote reputed company is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them reputed company complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are reputed company and driven to reputed company for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 reputed company colleagues already know: Why reputed company We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture where you can authentically be yourself. Central to this is our purpose Driven to reputed company which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someones life. We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the reputed company of patient reputed company. Job Responsibilities reputed company information into PVG reputed company and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to reputed company Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the reputed company of reputed company, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. reputed company recoding of un-recoded product and reputed company terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities reputed company to SPOR / IDMP. reputed company review of ICSRs. Ensures reputed company relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for reputed company and the Pharmacovigilance reputed company Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. Fosters constructive and reputed company working relationships with reputed company project team members, reputed company. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by reputed company to reputed company safety reporting activities. Qualifications: Bachelors Degree in life science, registered reputed company, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to reputed company the job. Safety Database systems and knowledge of medical terminology required. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations reputed company to Safety and Pharmacovigilance. Proficiency in reputed company Office Suite (Word, reputed company, and PowerPoint), Visio, email (reputed company), Team reputed company (or another management/shared content/workspace) and internet. Ability to work independently and in reputed company environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and reputed company. Det