Medical Doctor

Mandatory

Medical Doctor.

English fluently

Relevant experience in pharmacovigilance or drug development

Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities

Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.

Responsibilities

Responsible for signal detection and evaluation activities for assigned products.

Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.

Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.

Authors regulatory periodic reports (PSUR/DSUR/PBRER) and associated...