Named Safety Contact

vor 1 Tag


Shire Of Denmark, Österreich GlaxoSmithKline Vollzeit

Site Name: Vallensbaek Strand Delta Park Posted Date: Dec Job title: Full time Named Safety Contact (NSC) / Pharmacovigilance Specialist – Denmark & Iceland – with the possibility of converting to 0.8 position The Medical team in the Denmark & Iceland LOC is dedicated to safeguarding patient welfare and ensuring that all GSK medicines and vaccines are used safely and appropriately. The team partners closely with national regulatory authorities, cross-functional LOC colleagues, and global Patient Safety functions to maintain robust pharmacovigilance oversight and uphold the highest compliance standards. As part of the Medical organisation, the NSC is a central and influential contributor to patient safety governance and regulatory compliance within the LOC. The Named Safety Contact (NSC) is a critical role ensuring end-to-end local pharmacovigilance (PV) oversight for all marketed products and clinical trial activities across Denmark and Iceland. This role is highly cross‑functional and involves daily collaboration with Medical, Regulatory, Quality, and Commercial stakeholders, as well as external partners and authorities. The NSC combines hands‑on operational PV activities with a strong strategic influence, shaping local PV compliance frameworks and contributing to enterprise patient safety governance. We are looking for a candidate with communication skills and the ability to operate confidently in a complex and evolving regulatory environment. Core Safety & Compliance Responsibilities Oversee day-to-day pharmacovigilance activities for all Pharma, Vaccines, and ViiV products, including marketed products and clinical trials within Denmark and Iceland. Act as the primary LOC point of contact for all safety-related matters, ensuring alignment with global PV requirements and local regulations (DKMA/EMA). Maintain and continuously improve local written standards, SOPs, and PV routines to ensure compliance and inspection readiness. Ensure timely training of all LOC staff and relevant third parties in adverse event (AE) reporting and pharmacovigilance requirements. Support Country Medical Director and General Manager in local safety governance, including enterprise patient safety risk oversight and RMCB review processes. Secure ongoing surveillance of regulatory updates and translate them into operational LOC requirements. Strategic & Cross‑Functional Responsibilities Serve as a pivotal LOC stakeholder driving local PV oversight, risk assessment, and continuous compliance improvement. Navigate complex regulations and systems, providing expert interpretation and guidance to LOC leadership and global stakeholders. Lead or support PV aspects of audits and inspections, ensuring robust demonstration of local oversight and compliance readiness. Manage monitoring activities, including CAPA implementation and effectiveness tracking. Maintain oversight of PV-related third‑party obligations and ensure contractual compliance. Provide PV expertise to internal teams and contribute to cross-functional decision-making with potential impact on patient safety. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Master’s degree or equivalent academic qualification in a life science field (e.g., pharmacy, medicine, biomedical sciences). Minimum 3–6 years of experience in pharmacovigilance or a closely related regulatory/medical discipline within the pharmaceutical industry. Deep understanding of local and EU PV regulations, safety systems, and compliance requirements. Ability to interpret complex regulations, manage ambiguity, and make independent, high-impact decisions related to patient safety and regulatory compliance. Strong communication and stakeholder-management skills, with the ability to influence and collaborate cross-functionally at all levels. Demonstrated capability to ensure inspection readiness and lead audit-related PV activities. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Pharmacist degree or equivalent advanced scientific qualification. Experience working within GxP frameworks, global PV systems, and matrix organisational structures. Proven expertise in local risk assessments and enterprise patient safety governance. Experience engaging with regulatory authorities (e.g., DKMA, EMA) on PV-related topics. Familiarity with third-party oversight models and vendor management in a PV context. Closing Date for Applications 04 Jan 2026 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at (US Toll Free) or (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #J-18808-Ljbffr


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