inVentiv Health Safety Associate II | 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 II | Pune/Hyderabad
Job ID 14123
Process adverse event reports received from sites/reporters.
Perform QC review of completed individual and periodic safety reports.
Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.
Generate adverse event queries, liaise with the medical reviewers/client 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.
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.
Distribute safety data reports to other Safety Associate peer and Medical Monitor for review.
Distribute safety data reports to clients and other relevant parties.
Ensure compliance with company policies, procedures, and standards.
Participate in audits as required/appropriate.
Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects.
Mentor or train less experienced Safety Associates on processes regarding case management.
Perform literature review as appropriate for Post-Marketing cases.
Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
Any other duties as assigned by manger.
Bachelors Degree, preferably in a life science, nursing, pharmacy and two years of relevant with one year of safety/PV experience. Relevant experience could include data management, CRA, clinical practice, regulatory authority, or study coordinator experience
2-3 years safety/PV experience in case processing
Who can join immediately can be considered on priority
Having experience in Literature Case Processing will be added advantage
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
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
Excellent 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 spreadsheet software (MS Excel)
Ability to travel as necessary (less than 5%).
Country India [IN]