Performs active pharmacovigilance with rapid identification and analysis of safety signals, to define emerging drug safety profiles of all products and drive patient risk management. Provides integrated strategic safety expertise to clinical development programs. Collects adverse event data on all marketed products and those in development. Implements and manages adverse event processes and databases. Ensures regulatory compliance for both expedited and periodic reports. Delivers high-quality product safety data and analysis to internal and external customers throughout the product life cycle.
An opportunity exists for a motivated individual to become a full time Triage Case Manager. Working as part of global team, you will be responsible for the maintenance of the GCSP Global Adverse Events Inbox and management of the Combination product triage email inbox. This includes timely intake and triage of case reports received globally and the book in process for data entry in to the Global Safety database.
The responsibilities of the Case Manager will include:
•Maintenance of the Combination product email inbox and Global Adverse Event inbox.
•Triage of potential adverse event reports, assessing seriousness and priority
•Perform duplicate check in the global safety database to avoid duplicate reporting to regulators
•Recording triage assessments in the Trackwise database
•Prompt and accurate data entry into the safety database
•Coding of all adverse events using the regulatory required MedDRA coding terminology
•Determination of the significance of follow-up information
•Full and independent processing of invalid case reports as well as reports of use in special circumstance without adverse event.
To be successful
You are a Pharmacist, Registered Nurse, or hold a BS/BA and have experience in pharmacovigilance or the Pharmaceutical Industry. Preferably, you have global pharmacovigilance database knowledge and are familiar with related local and global regulations.
Applications must address the selection criteria above and include a current CV and covering letter.
Requires a Registered Nurse, BS/BA, Physician Assistant, Pharmacist.
At least 1 year of medical/surgical nursing or a similar setting and 3 years of experience in pharmacovigilance, or equivalent setting. Global pharmacovigilance database knowledge is preferred along with proficient knowledge of global regulatory regulations and device exposure.
•Good knowledge of drug safety processes, pronounced expertise in Single
Case Management, in particular in terms of database, triage, and case entry
•Knowledge on CSLs product portfolio and strong understanding of medical terminology
•Strong sense of responsibility and accountability and special sense for diligence even for routine processes, proactive behavior and being able to keep timelines.
•Very good knowledge of AE and drug coding conventions (MedDRA,
•Good knowledge of ICH principles of SAE/AE reporting along with basic understanding of local and global regulatory roles and regulations
•Ability to develop cooperative working relationships
•Verbal and written communication skills in English language
•Knowledge in Good Documentation Practices & Good Pharmacovigilance Practices
•Oral and written communication skills, ability to identify problems in case entry and to assist in implementation of workable solutions,
•Good knowledge of standard office software packages (Outlook, Word, Excel).
•Preferred Trackwise knowledge
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