Safety Specialist, Pharmacovigilance Case Processing

Location: Sweden; remote work is supported, with hybrid work encouraged for new hires within a reasonable commute of an office.

Company

hirify.global provides consulting and operational solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Process daily clinical-trial and post-marketing adverse-event cases.
• Code events using MedDRA and assess seriousness and expectedness at event and case level.
• Identify follow-up information requirements, create and review medical narratives, and issue client notifications.
• Submit cases meeting expedited reporting criteria to regulatory authorities according to applicable procedures and regulations.
• Support training material development and delivery, escalate ICSR concerns, and perform peer reviews for quality and accuracy.

Requirements

• Bachelor’s degree in life sciences.
• Two years of related work experience.
• Basic knowledge of pharmacovigilance and global medicine safety regulations.
• Strong written, verbal, and interpersonal communication skills with high attention to detail.
• Ability to work independently and collaboratively, prioritize tasks, multitask, and resolve problems promptly.

Nice to have

• Advanced degree, RN, RPh, PharmD, or equivalent qualification.

Culture & Benefits

• Remote working is supported, with hybrid collaboration available for employees located near an office.
• Inclusive workplace focused on diversity, equity, and belonging.
• Environment encouraging innovative, collaborative, and entrepreneurial contributions.
• Applications are personally reviewed by the recruitment team without AI screening tools.

Hiring process

• Applications are reviewed personally by a member of the recruitment team.
• Applicants receive an outcome regardless of whether they are selected.