Pharmacovigilance Specialist (1-Year Maternity Cover)

Zvh; Silkeborg; On-site; DKK 700,000 - 900,000; Full time

Job summary

Baxter is hiring a Pharmacovigilance Specialist to support Nordic PV activities, ensuring local systems meet European and national rules. The role collaborates with UK PV teams and regulatory bodies across Denmark and Sweden, handling ADRs, trials, audits, and compliance.

The candidate should hold a Life Sciences or related degree with 3–5 years PV experience and fluency in Danish, Swedish, and English. The position is based in Soborg, Denmark, or Stockholm, Sweden.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field.
• 3-5 years of experience in Pharmacovigilance or Drug Safety.
• Fluent in Danish, Swedish, and English with strong communication skills.

Responsibilities

• Collect and document local adverse events following SOPs.
• Transmit reports to GPS in a timely manner and respond to queries.
• Act as PV representative during inspections and audits.
• Collaborate with country QA and EMEA PV teams on PV clauses and agreements.
• Perform local PV activities including literature reviews and regulatory intelligence.

Skills

Pharmacovigilance

Drug Safety

Stakeholder management

Regulatory awareness

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

This is where your 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

• 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.

Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.