inVentiv Health Safety Associate I | 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 Associate I | Pune/Hyderabad
Job ID 14126
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
Bachelor’s Degree, preferably in life science, nursing, or pharmacy
1-2 years of safety/pharmacovigilance.
Familiarity with safety database systems; ARISg or ARGUS preferred.
Who can join immediately can be considered on priority
Having experience in Literature Case Processing will be added advantage
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 communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
Country India [IN]