Specialist Safety Operations
Key information
- Publication date:28 November 2024
- Workload:100%
- Contract type:Temporary
- Place of work:-, 2000 neuchâtel
Do you want to join Philip Morris Neuchâtel?
Do you want to join Philip Morris Neuchâtel?
We are looking for a candidate who can pivot from the usual ways of working, someone inquisitive, solution oriented and willing to think and operate innovatively.
Your role will be to manage the assigned safety surveillance activities for the Reduced Risk Products (RRPs) including but not limited to:
At PMI, we are using an automated safety database which requires a shift in typical case management and a robust bridge between safety operations and system teams. As a result, we are looking to develop a safety operations specialist to support the case management operational excellence and take it to the next level in the fast-paced environment of artificial intelligence.
We are looking for a candidate who can pivot from the usual ways of working, someone inquisitive, solution oriented and willing to think and operate innovatively.
Your role will be to manage the assigned safety surveillance activities for the Reduced Risk Products (RRPs) including but not limited to:
- WF liaison: ensure seamless flow of cases into LSMV workflows, coordinating the WF management between the safety service provider and the different CSC stakeholders.
- QA liaison: ensure inspection readiness at alltimes, be the case management Subject Matter Expert for audit/inspection.
- System liaison: identify process gaps and system failures, coordinate the necessary enhancement with the safety systems team.
- Responsible for the safety mailbox monitoring: oversee case processing workflow from Initial to Exit step, coordinate case progression through workflow, support call centers and safety service provider in case prioritization and execution.
- Case management activities:
- review of serious cases (Quality Review) and coordination of follow-ups, submission of reportable cases to the markets (Distribution)
- coordinate literature and non-sponsored social media screening
- support clinical trial activities: SAE processing and reconciliation
- support adverse event and LSMV trainings
- Identify opportunities for process improvements and liaise with the safety database team for further assessment/implementation.
- Contribute to impact assessment and implementation of configuration changes, assess potential impact on automation/case processing KPIs.
- Responsible for case management related workaids, assess impact of process changes on the PSS QMS document.
- Be the case management SME and ensure audit/inspection readiness for PSS.
- Graduated with a BSc or MSc in life sciences.
- 3-5-year experience in the pharmaceutical industry, in a safety/pharmacovigilance department.
- Strong experience in processing adverse event reports, safety database knowledge is a must (LSMV is a plus).
- Flare for new technologies and IT systems with good investigational skills.
- Good knowledge of EU pharmacovigilance regulation (GVP).
- Strong verbal and written communication and documentation skills required, with high attention to detail.
- Willing to learn and able to work independently in a dynamic corporate organization, under pressure of tight deadlines.
- Ability to prioritize the workload with strong time management skills.
- UE27/AELE nationality or a valid Swiss Work Permit required for this position due to legal compliance in Switzerland.
Don't hesitate to apply.
Contact
- Suzana Sorrenti
