inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality.
Post: Safety Associate I
Job Description:
- Complete data entry in safety database including writing of adverse event narrative and preliminary assessment of event seriousness and expectedness/listedness as per Reference Safety Information.
- Generate adverse event queries, liaise with the medical reviewers and clients to agree upon the queries, and send request for additional information to the sites/reporter.
- Engage with the Site Monitors to ensure follow up information is obtained from site effectively.
- Forward safety report documents to designated medical reviewer for review.
- Forward completed safety report documents to clients and other relevant parties.
- 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).
- Ensure case files are compliant with SOPs.
- Interact and communicate effectively with other company departments/functions such as project management field monitoring, data management, etc. to ensure the highest level of client satisfaction through successful execution of projects.
- Perform literature review as appropriate for Post-Marketing cases.
- Maintain knowledge of legislation, guidelines and regulations relating to safety and PV reporting applicable to countries where inVentiv Health Clinical manages safety responsibilities.
- Provide support for PV Lead with miscellaneous project tasks relating to safety reporting. Participate in audits as required/appropriate.
- Any other duties as assigned by manager
Candidate Profile
Bachelor’s Degree, preferably in life science, nursing, or pharmacy 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.
Good 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 communications, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
Ability to travel as necessary (less than 5%)
Additional Information:
Location: Pune/ Hyderabad
Industry Type: Clinical Research
Functional Area: Other
Job ID: 13120
Last Date: 12th August, 2016
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