Drug Safety Submission Specialist (Remote, Argentina)

About the role

The Drug Safety Submission Specialist will support a global pharmaceutical consulting organization by managing pharmacovigilance safety submissions for an innovative medicinal product in Argentina. Working remotely, the contractor will ensure all safety reports meet local regulatory requirements and are submitted on time.

Key responsibilities

• Prepare, review and submit pharmacovigilance safety reports to ANMAT.
• Manage expedited reporting, including SUSAR submissions.
• Compile and submit Development Safety Update Reports (DSURs).
• Execute submissions through the Argentine TAD platform in line with local guidelines.
• Maintain accurate documentation and submission records.
• Coordinate with global pharmacovigilance, regulatory affairs and sponsor teams.
• Monitor deadlines, resolve queries and provide guidance on local submission processes.

Required profile

• Bachelor’s degree in Pharmacy, Life Sciences, Medicine or a related scientific discipline.
• Proven experience with pharmacovigilance safety submissions in Argentina.
• Hands‑on experience submitting SUSARs and DSURs.
• Valid Argentine National ID (DNI).
• Strong organizational and communication skills.
• Ability to work independently in a remote, project‑based setting.

Required skills

• Use of the TAD submission platform.
• Knowledge of Argentine pharmacovigilance regulations and ANMAT requirements.