Global Drug Safety Associate - abroad

The Global Drug Safety Associate will be instrumental in the technical activities of the Global Drug Safety department, offering cross-functional support while ensuring the delivery of high-quality, compliant services. This role involves executing project-related tasks, collaborating with internal and external stakeholders, and improving processes to enhance operational efficiency.

What will be your key responsibilities:

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.

What experience should you have:

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.

Key Attributes We Value:

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.

What do you get in return:

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!

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