Pharmalex has an exciting opportunity for a Pharmacovigilance Expert to join our thriving team in the Nordics!
- Set up and manage the local pharmacovigilance system
- Local Literature Search
- Local ICSR Management
- PV Intelligence Screening
- Local PSMF Maintenance
- Setting up local Organized Data Collection
- Local PVA Management
- Local adaptation and submission of PSUR / RMP
- Local signal detection
- Implementation of additional Risk Minimization Measures
- Reviewing materials relating to local post-authorization safety
- Participate in PV-relevant audits and inspections
- Attend regular meetings according to project meeting schedule
- Provide monthly PV report on status of local PV system in the country/ies
- Ensure PV training of affiliate employees, service providers and Third Parties
- Close cooperation with the global PV system of the client as well as related global and local departments and functions
- Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
- Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
- Deputy is assuming responsibility in case of planned or unplanned absence
- The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.
Operational lead:
- Escalate staffing necessities to LPV Regional Lead.
- Identify and escalate to the corresponding LPV Regional Lead any issue occurring in an LPV program impacting the services in the corresponding country/ies.
- Assist the LPV Regional Lead on the coordination of the induction training plan to LPV local resources.
- Communicate LPV staffing issues and departures to LPV Regional Leads and Team Leads.
- Implement LPV programs including program Sharepoint.
- Prepares the PSA Calculation Tool and supports PRO on PSA drafting.
- Inform Procurement and partners about PSA termination
- Initiates and coordinates program deviations in Master Control.
- Program KPI definition and monitoring.
- Working Practice coordination and execution.
- Monitoring program training compliace with support of the PER compliance team
- The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.
We are looking for an experienced individual who has at least 5 years working experience within local Pharmacovigilance. We are also looking for knowledge of a Nordic language (Swedish, Finnish, Danish or Norwegian).