Input to high-quality and timely responses to safety queries
Ensure completion of basic training in case handling. Undergo additional training as required, such as writing a full narrative and PSUR comment.
Ensure sign off in A, B and non-expeditable c (C-EU, C-KUR/DME) cases prior to processing expeditable C cases
Ensure sign off on expeditable C cases (C-SSAR, C-SUSAR)
Ensure compliance with global and local procedural documents and local implementation of the client and TCS, policies, processes and procedures
Enter initial and follow-up information for individual adverse event case reports of higher business value onto the global Patient Safety database, using data interpretation, coding and writing skills in accordance with the current Data Entry Process Instructions and associated SOPs and OPIs, to ensure consistency of case entry and high data quality standards
Perform self QRE on cases
Perform all activities within the required timeframes to ensure regulatory compliance
Ensure that the appropriate Global Safety Physician is made aware of any adverse event which may have medical, regulatory, legal or other consequences so that it can be managed in accordance with procedures
Support a performance-driven culture
Patient Safety Specialist+ can act as a KPI after receiving all specific training/hands-on training.
All Patient Safety Specialist+ can act as TCS Mentor based on their performance.
· Qualified to degree level in life sciences or an appropriate healthcare or pharmaceutical industry background
· An understanding of the international regulatory requirements for single case expedited reporting and periodic updates is an advantage
The role holder will have:
· Knowledge of medical terminology
· An understanding of the principles and concepts associated with Patient Safety case-handling process, including regulatory reporting requirements for single case expedited reporting and periodic updates
· Patient Safety policies, processes and procedures knowledge
· Ability to prioritize schedule and organize.
· Attention to detail.
· Excellent interpersonal and communication skills.
· Able to work independently, guided by procedures, with appropriate support
· Able to work effectively as part of a team
· Demonstrable communication skills
· Good time management
· Fluent in English
· Computer literate