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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Education / Training |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
SR. DRUG SAFETY ASSOCIATE-As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needsTravel (up to approximately 10%) domestic and/ or international as applicable Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processesReview and process serious adverse events, spontaneously reported adverse reactions and/ or other medically related information per assigned tasks and study specific proceduresProvide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project filesAttend project team meetings and teleconferences as requiredServe a resource for investigational sites and ICON personnel on safety-related issuesAssist with training/ mentoring newly hired DSA staff, as requestedAssist with identifying out of scope activities in conjunction with the MSS Functional LeadAssist with generation of study specific proceduresLiaise with Sponsor and attend Sponsor meetings, as requiredPerform safety review of clinical and diagnostic dataLiaise with investigational site, reporter, and/ or Sponsor as necessary regarding safety issuesLiaise with ICON project manager, and other departments, as appropriateAssist the MSS Functional Lead under supervisionAct as lead DSA for local or regional projectsPerform other activities as identified and requested by managementSalary: As per company normsExperience: 4-10 YearsIndustry: Pharma / Biotech / Clinical Research with EducationFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, BiotechnologyRole Category: R&D & TrainingRole: Sr. Drug safety AssociateEmployment Type: Permanent Job, Full TimeKey skills: Pharmacovigilance, Eudravigilance, Oracle Argus, Aggregate Reporting etc,
Keyskills :
caseprocessing pharmacovigilance safety case dataentry drugsafety adverseevents trackingsystems clinicalresearch processimprovement dsa mss icon argus pharma medical research egulat yrequirements acle bu