About this role
Summary: The Pharmacovigilance Specialist for the Nordics is responsible for: in collaboration with the Pharmacovigilance Manager, to maintain an efficient local Pharmacovigilance system in the Nordic countries meeting the European and national regulations and in compliance with the Baxter Pharmacovigilance procedures. To ensure appropriate contacts with the other organizations not limited to country Regulatory Affairs, Country Quality Assurance, Business Units and with HCP and Competent authorities (MPA, FIMEA, DMA, NOMA, IMA). To work closely with the PV team based in UK according to the cluster model.
Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
3-5 years of experience in Pharmacovigilance, Drug Safety, or a related healthcare/pharmaceutical role.
Fluent in Danish, Swedish, and English, with strong verbal and written communication skills.
Strong attention to detail and ability to manage multiple priorities in a regulated environment.
Excellent collaboration and stakeholder management skills.
Ability to work effectively both independently and as part of a cross-functional team.
Full list of responsibilities
The PV Specialist is accountable and responsible for the following activities:
1. ADR Reporting
- To collect, document, follow-up all local AEs and other pharmacovigilance information (e.g. pregnancy, medication error, lack of efficacy) from all sources according to SOPs
- To transmit all reports to GPS (Global Patient Safety) in a timely manner
- To make all efforts to answer the queries of the GPS organization and to use the specific follow-up questionnaires
- To answer the safety questions from the Health Care Professionals with the support of the cluster PV Manager, PV Director and the GPS organization, and Medical affairs if necessary
- To close and archive ADR reports according to SOPs
2. Clinical trials activities
- If stated in the protocol, to process the SAEs and transmit them to the GPS according to SOPs.
3. Audits and inspections
- To act as local PV representative during inspections and audits, actively participating to the inspection/audit during interview sessions and providing document requests
- In coordination with the cluster PV Manager, EU-QPPV office and GPS, to investigate and provide/ support responses to inspection and audit findings, and implement Corrective and
Preventive actions
4. Agreements with third parties
- To collaborate with agreement owners, country QA and with the EMEA PV agreements team to ensure that any relevant Agreement with Third Party include appropriate PV clause or full SDEA
- To support the EMEA PV Agreement team in the implementation of local PSPs/MRPs, in collaboration with the initiator
- To notify safety signals to third party (distributor or PV supplier) in country/cluster as per procedure
- To perform reconciliation of Adverse Events with third party/PV Service Supplier
5. Other local PV activities
- To be involved in the communication on PV topics with national Competent Authorities, and supports answers preparation in cooperation with cluster PV Manager, GPS and Eu QPPV
- To perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures
- To alert the cluster PV Manager about any safety related issues without delay
- To prepare highlights as needed and represent PV at Nordic Quality Review Meeting (QMR)
- To be aware of required local risk minimization activities
- To perform local literature review, including assessment of local journals for screening, as described in SOP
- According to the process established at EU level, to validate the comparative table prepared by RA to put CCDS/CCSI/RSI and the local SPC in conformity
6. Regulatory intelligence
- Local regulatory intelligence: To regularly screen the websites of Competent Authorities in The Nordic countries for safety signals, Pharmacovigilance newsletters, regulations, etc
- To inform Pharmacovigilance Manager, EU QPPV and GPS on relevant changes concerning National regulations
7. Training
- To perform trainings as required and keep up to date personal training records.
- To provide appropriate training on PV to new employees, partners and vendors
- To keep up to date records of the internal Pharmacovigilance trainings made to Baxter employees, partners or vendors
- To assist in onboarding and training of new team members
8. Procedures
- To create, issue, implement and update local Pharmacovigilance related procedures as needed, in collaboration with the cluster PV team and Manager.
- To implement global Pharmacovigilance SOPs.
9. Compliance
- To closely monitor local compliance and ensure all efforts are made to achieve high compliance rates.
- To open process errors according to SOPs and help in the resolution of noncompliance Reports
10. Activities related to associated countries in the Cluster
- To collaborate closely with the UK Team members on above activities and provide any relevant information or support according to the cluster model