Responsibilities :

• Perform as Local Contact Person responsible for Pharmacovigilance.
• Perform local literature search / review or quality control on results, maintain local journal / conference lists.
• Handle case reports, complaints, queries (from collection to reporting to Client / Authorities).
• Prepare / review aggregate reports (e.g. PSURs / PBRERs).
• Prepare Risk management Plans.
• Assist in handling / monitoring additional risk minimization activities.
• Handle communication with external stakeholders (Clients, regulators, local collaborators etc.).
• Submit or assist with submission of vigilance related documents and reports.
• Working in other aspects of product safety (e.g. PV system maintenance).