Trainee - Pharmacovigilance Jobs in Bangalore - IMEDGlobal Solutions India Ltd
Job Description
- Receive review
requests via email, create an activity folder for all relevant communications,
and add to work tracker
- Review project management tool entry for correct entry
of relevant fields per procedural document criteria and if not present, document
issue and send query to Activity Manager for correction and update work
tracker. Continue to monitor until resolution
- Ensure that
activity has been entered the safety tracking system known as TMS. Perform
checks on TMS entry as defined in procedural documents to ensure that the
Activity Manager is updating TMS entry as required, including close-out.
Follow-up with Activity Manager as appropriate for resolution of any issues
with entry that require actions (e.g. updating entry).
- Perform entry
into TMS for those countries that an Activity Manager is unable to perform this
entry per defined procedures
- Verify if
supplier contracts have correct PV language and has been correctly identified
in the International Contract Database (ICD) as Pharmacovigilance System Master
File (PSMF) relevant
- Verify that there
is a management plan for the collection, reporting and reconciliation of safety
data. If not present, query Activity Manager for plan and continue to monitor
until resolution.
- For those
countries that require HUB support for management plans, document a management
plan as per local country requirements for managing safety data
- Receive and
process supplier training requests
- Review training
records to identify whether training is required and ensure Learning Management
System (LMS) administrator has assigned training as applicable
- Monitor
completion status via LMS and follow up with Activity Manager when trainee is
overdue
- Run training
reports as required
- Monitor mailbox
and escalate any queries from business to HUB team member for resolution
- Verify if reconciliation forms are being returned per
the management plan. Follow up with Activity Manager when reconciliation form
is missing and continue to monitor until resolution
- Ensure relevant study documents are in correct repository per defined
procedures.
Job Particulars
About Company
iMEDGlobal Solutions is a leading service provider in the fields of Regulatory Affairs, Medical Affairs, Pharmacovigilance, Toxicology and Clinical Operations services to pharmaceutical, biotechnology, and medical device industries worldwide. In October 2016, iMEDGlobal merged with FMD K&L to expand our services portfolio and increase our global reach. Following the merger, our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. Our experience in utilizing domain knowledge and technology help us deliver services distinguished by quality, experience, and timeliness.
