SERM

We are looking for a SERM - Safety Evaluation and Risk Management professional who wants to learn and transform their career.

Mandatory Qualifications

• 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...