inVentiv Health Safety Assistant | Pune/Hyderabad in Pune, India
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients' therapies to market.
Title Safety Assistant | Pune/Hyderabad
Job ID 14125
Manage and process adverse event reports.
Maintain systems to ensure compliance with case processing and tracking.
Triage and track incoming adverse event reports within one business day of receipt
Assign case numbers to the adverse event report and perform initial skeleton entry into the safety database.
Manage the translation process for any source documents needing service.
Foster constructive and professional working relationships with all project team members, internal and external.
File documents according to project specific requirements (electronically or in hard copy as applicable).
Maintain knowledge of legislation, guidelines and regulations relating to safety and PV reporting applicable to countries where inVentiv Health Clinical manages safety responsibilities.
Assist safety associates and management GSPV as required.
Participate in audits as required/appropriate.
Any other duties as assigned by manager.
Qualified Graduate, preferably from Medical or Life Science Background
Fresher or 0-1 Years’ experience in any of Clinical Operations applicants can apply
Ready to join immediately
Familiarity with safety database systems; ARISg or ARGUS preferred.
Ability to successfully prioritize and work on multiple tasks.
Excellent team player and attention to detail.
Knowledge of ICH guidelines and regulations relating to safety reporting.
Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS PowerPoint), email software (Outlook), diagramming/workflow software (MS Visio), and spread sheet software (MS Excel).
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Country India [IN]