Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in securing the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry.

Assignment Description:

We are looking for a Senior Pharmacovigilance Safety Officer to join our dynamic team

What You Will Work On:

• Monitor regulatory changes and assess their impact on vigilance activities and responsibilities.
• Conduct reconciliations with various departments, including distributors, third parties, vendors, and internal stakeholders.
• Ensure proper identification of local literature articles for adverse event (AE) reporting.
• Prepare and submit safety reports, updates, and information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other relevant departments.
• Assist the Area Safety Lead in responding to safety-related queries from health authorities within the territory.
• Support the Area Safety Lead in notifying local health authorities of any safety issues, including SSI/ESI and Signals.
• Stay informed about local requirements for pharmacovigilance, cosmetic, and device vigilance, including reporting obligations for all applicable product classes in the territory. Collaborate with the global team to implement necessary process changes to address new requirements.
• Document self-identified non-conformances and collaborate with the global team to investigate them, developing and implementing effective Corrective and Preventive Actions (CAPAs).
• Undertake other tasks as assigned by the manager.
• Manage document handling and archiving as needed.
• Provide training on safety reporting responsibilities to local personnel and maintain awareness of safety reporting practices.

What You Bring:

• Fluency in Swedish and proficiency in English.
• Strong understanding of regulatory requirements related to pharmacovigilance, cosmetics, and device vigilance.
• Experience in safety reporting and submission processes, including knowledge of various safety report types.
• Ability to communicate effectively with internal and external stakeholders.
• Excellent organizational skills and attention to detail.
• Capability to manage multiple tasks and prioritize effectively.
• Proficient in document management and archiving practices.
• Previous experience in conducting training sessions is desirable.
• Bachelor’s degree in a relevant field preferred.