Job Description:-
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 needs
Travel (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 processes
Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
Attend project team meetings and teleconferences as required
Serve a resource for investigational sites and ICON personnel on safety-related issues
Assist with training/mentoring newly hired DSA staff, as requested
Assist with identifying out of scope activities in conjunction with the MSS Functional Lead
Assist with generation of study specific procedures
Liaise with Sponsor and attend Sponsor meetings, as required
Perform safety review of clinical and diagnostic data
Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
Liaise with ICON project manager, and other departments, as appropriate
Assist the MSS Functional Lead under supervision
Act as lead DSA for local or regional projects
Perform other activities as identified and requested by management

Salary: As per company norms

Experience: 4-10 Years

Industry: Pharma / Biotech / Clinical Research with Education
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D & Training
Role: Sr. Drug safety Associate
Employment Type: Permanent Job, Full Time
Key skills: Pharmacovigilance, Eudravigilance, Oracle Argus, Aggregate Reporting etc