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We are looking for a Pharmacovigilance Specialist to join our team on a 1-year maternity cover contract, based in Soborg, Denmark, or Stockholm, Sweden.

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

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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