Pharmacovigilance Specialist – Submissions (Remote)

About the role

ProPharma is seeking a Pharmacovigilance Specialist focused on submissions to support its global clients. The role works remotely within a multi‑tenant Argus environment, ensuring that adverse event reports and periodic safety reports meet the requirements of health authorities, ethics committees, and safety partners.

Key responsibilities

• Monitor daily scheduled expedited and non‑expedited individual case safety report (ICSR) submissions and exchanges.
• Generate and reconcile monthly ICSR reports with clients and safety partners.
• Produce Argus‑based line listings and summary tabulations for Periodic Safety Reports.
• Assist in testing gateway‑to‑gateway submissions and E2B profile configurations for new territories or product types.
• Participate in performance qualification (PQ) testing for Argus upgrades, patches, and data migration projects.
• Create, close out, and track submission‑related deviations and associated CAPAs.

Required profile

• Post‑secondary education in life sciences or equivalent professional experience.
• Minimum C1 level of English.
• At least 2 years of proven experience in pharmacovigilance submissions or related regulatory reporting.

Required skills

• Proficiency with the Argus multi‑tenant database.
• Knowledge of E2B data exchange standards.
• Experience conducting performance qualification (PQ) testing.
• Familiarity with data migration processes for safety databases.