Pharmacovigilance Specialist (1-Year Maternity Cover)

Baxter Healthcare; Søborg; On-site; DKK 550,000 - 750,000; Full time

Job summary

Baxter Healthcare in Denmark is seeking a Pharmacovigilance Specialist to support the Nordics from Soborg or Stockholm. You will maintain an efficient local PV system, ensure regulatory compliance, and collaborate with regional and UK teams to manage safety data and inspections.

The role covers ADR reporting, regulatory intelligence, training, and PV process improvements, with a focus on cross-functional coordination and high compliance within a challenging, regulated environment.

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.

Responsibilities

• ADR reporting: collect, document, and follow up local AEs; transmit reports to GPS.
• Clinical trials: process SAEs per protocol when stated.
• Audits: act as local PV representative during inspections and audits.
• Regulatory/Third parties: collaborate to ensure PV clauses and PSPs/MRPs are implemented.
• Local PV activities: communicate with national authorities and provide training and updates.

Skills

Fluent in Danish

Fluent in Swedish

Fluent in English

Attention to detail

Stakeholder management

Cross-functional teamwork

Education

Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

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 elevate 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.