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...