Enter reports of drug side-effects from post-marketed or clinical study source to the safety database. Handle non-serious and serious cases according to regulatory requirements, process instructions and standard operational procedures. Resolve queries related to pharmacovigilance activities and individual case reports.
- Overall accountability of day-to-day case processing activities including Service Level Agreement monitoring and focusing on compliance.
- Ensuring adequate resource availability in Drug Safety teams to support Drug Safety activities.
- Participating in recruitment and selection of team members.
- Accountable for proactive workload management within their teams and across the function to ensure that internal and regulatory timelines are met.
- Collaborating with other Team Leaders, Team Manager, Project Manager to discuss work load and proposed solutions to fluctuating work load as needed.
- Responsible for providing clear and concise communication to the function regarding changes and updates to caseload.
- Proactively identifying trends in compliance and proposing solutions to case processing and resourcing issues.
- Ensuring compliance to SOPs and other process related documentation across the function.
- Ensuring that special coaching or training is provided on any topic required by any Data Entry Analyst/Trainer/Quality Analyst/ Medical Safety Analyst to ensure that the individuals are appropriately trained for their role.
- Monitoring the roles and responsibilities of Data Entry Analyst/Trainer/Quality Analyst/ Medical Safety Analyst to ensure that all responsibilities are fulfilled.
· Bachelor’s Degree in Life Sciences or Healthcare degree.
· Advanced competency with medical and therapeutic terminology
· Minimum 2 years of experience in pharmacovigilance.
· Previous leadership experience in cross-functional teams or projects in a global environment
· Previous process/workflow coordination
· Strong leadership skills, communicates and demonstrates vision and commitment
· At least basic Italian