Takes on challenging new role harnessing interpersonal skills, collaboration and problem-solving. Driven to deliver high-quality service and consistent results.
Responsible for assessing and processing safety information into the Global
safety database. Responsibilitiesinclude:
o Processing safety information according to applicable regulations,
guidelines, Standard Operating procedures (SOPs), Work Instructions
(WIs) and Service Level Agreement (SLA) timelines. Responsible for
assessing and processing safety information into the Global safety
database.
o Processing safety information according to applicable regulations,
guidelines, Standard Operating procedures (SOPs), Work Instructions
(WIs) and Service Level Agreement (SLA) timelines.
o Safety database entry: including duplicate check, coding adverse
event, products, medical history, laboratory data, reviewing and
amendments to auto-narratives and to perform E2B case validations.
o Initiating case specific queries to respective hubs.Data entry of drugs and processing various serious and non‐serious.
Data entry of drugs and processing various serious and non‐serious.Initiating case specific queries to respective hubs. Processing various
serious and non‐serious ICSR safety data received from various
sources which includes but not limited to Licensing Partners,
Regulatory Authorities, social media, and other spontaneous, PMS MR
and literature (AAPCC) sources with good quality and productivity.
Accurate coding of products and events in line with the client
specifications. Knowledge of ICH GCP guidelines.
I here by declare that the above-mentioned details are genuine to the best of my knowledge.