Position

 Overview: Basic Functions & Responsibilities

 The Pharmacovigilance (PV) Intern is responsible for the day-to-day case management activities within China covered by the country operation including compliance with PV processes and regulations and Organon policies and procedures. He/she can function independently in the processing of adverse events including: case management Health Authority (HA)

 submissions, archiving, etc.

 As requested by line manager, the PV Intern may undertake other additional activities including projects as requested.

Primary

Activities:

1/Responsible for day-to-day adverse experience case management within China covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Organon’s procedure and China regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.

3/Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System,following department SOPs, company Policies and Procedures and China legislation

QUALIFICATIONS:

Background Requirements:

The incumbent must have a health, life science, or medical science degree or equivalent by education /experience and be fluent in English (written and spoken) while proficient in local language. He/she must have an awareness of Pharmacovigilance regulations in China. The PV Intern is expected to have strong communication and time management skills and can work independently with minimal supervision.