Responsibilities
- 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
- Address Medical Information requests (MIR) from multiple programs and sources using approved response documents.
- Ensure that all the MIR are processed and documented according to PLx and client procedures, and project working practice.
- Identify and document adverse events (AE), product complaints, and quality issues according to PLx and clients’ procedures.
- Report AE information to the pharmacovigilance department.
- Collaborate with PLx and client's internal teams, including regulatory, medical affairs and marketing to provide scientific support as needed.
- Participate in client's product training, diseases and therapeutic areas, as per project requirement.
- Support project team on any report clarification, metrics, volumes, KPIs and compliance investigations.
- Escalate L2 MIR as per project agreement.
- Support in internal and external audits.
- Perform quality control of MIR to ensure adherence to project requirements and procedures.
- Reconcile medical information reports with adverse events and product quality complaint reports within the agreed timelines.
- 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.
Requirements
- Professional education or University degree in Life Science.
- Basic understanding/knowledge in the field of pharmacovigilance and medical information.
- Fluency in Finnish
- Ability to prioritize and manage own time and tasks.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
- Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.
- English business fluent.
Benefits
- Rekabetçi toplam ödül programı sunuyoruz.
- Çalışanlarımıza olan bağlılığımız, çalışan nüfusumuzun çeşitli ihtiyaçlarını karşılamak için kapsamlı, çeşitli ve tasarlanmış fayda programları içerir.
- Birçok sosyal hak şirket tarafından karşılanırken, diğerleri çalışan katkıları ile sağlanır.
- Belirli sosyal hak teklifleri konuma, pozisyona ve/veya iş birimine göre değişebilir.
- Tam zamanlı
Team
Structure: Close cooperation with the global PV system of the client as well as related global and local departments and functions.
Additional Information
- Affiliated Companies: PharmaLex Nordic ApS
- Language requirement: Fluency in Finnish
- Language requirement: English business fluent
- Equal Employment Opportunity: AmerisourceBergen provides equal employment opportunity regardless of race, color, religion, gender, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other class protected by federal, state or local laws.
