Global Drug Safety Associate

Project Execution:

• Support local pharmacovigilance (PV) initiatives, including literature monitoring, ICSR processing, compliance tracking, and reporting.
• Handle adverse event (AE), SAE, and SUSAR report processing, ensuring accurate database entry, MedDRA coding, and coordination of medical reviews.
• Facilitate expedited submissions and safety data reconciliation.

Global Drug Safety Tasks:

• Assist with global literature monitoring, regulatory intelligence, and safety information management (SmPC, IB).
• Oversee medicinal product data (e.g., XEVMPD) and contribute to safety management plans, contracts, and agreements.

Regulatory and Compliance Support:

• Support signal management, benefit-risk assessments, and regulatory adherence.
• Provide training on safety processes and standards to teams.

Administrative and Operational Excellence:

• Prepare, revise, and organize documentation; manage safety mailboxes and reports.
• Collaborate on audits, inspections, and vendor communications while ensuring departmental tracking compliance.

Qualifications and Skills:

• A bachelor’s degree in pharmaceutical sciences, medicine, or related fields (advanced degrees preferred).
• 1+ years of experience in medical or safety departments with knowledge of medical terminology and global drug safety processes (ICH, GVP, GCP, etc.).
• Experience working with safety databases (preferred).
• Strong organizational and time-management skills with the ability to prioritize tasks and meet deadlines.
• Excellent communication skills and a collaborative mindset.
• Proficiency in English, both written and verbal.

• Dedicated: Committed to delivering exceptional, client-focused solutions.
• Innovative: Proactively driving forward-thinking ideas and improvements.
• Passionate: Enthusiastic about making a meaningful impact in global drug safety.
• Inclusive: Respectful of diverse perspectives and fostering equity in every interaction.

Offer:

• Flexible Work Options: Remote working flexibility to support your lifestyle.
• Generous Time Off Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
• Home Office Support: Get support to create a productive home office setup.
• Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
• Dog-Friendly Offices: Bring your furry friend to work in our dog-friendly offices!