Pharmacovigilance Director
A position has arose, to work with a global pharmaceutical company. This is a fantastic opportunity to be part of a well-funded business to grow this is a truly exciting time to join the company.
With their growth plans, they are looking for a Pharmacovigilance Director which will be a part of the Global Safety Department, frequently collaborating with other safety staff and other groups such as clinical development and regulatory affairs, and working within a fast paced environment.
Responsibilities, though not limited to:
• Conducting routine pharmacovigilance activities, signal detection/evaluation and leading authoring of key regulatory documents (e.g. DSURs, EU RMPs and PBRERs).
• Leading the monitoring and evaluation of safety data.
• Ensuring studies are designed and delivered with a focus on the safety of participants and safety objectives.
• Ensuring that all safety documentation is accurate and available to meet global compliance and regulatory requirements.
Qualifications:
• Significant experience with Safety Evaluation and Risk Management.
• Relevant degree/high-level degree qualification.
• Experience of international pharmacovigilance requirements such as ICH, GVP modules, CIOMS initiatives.
• Experience with drug development and approval processes.
If you are interested in growing your professional career please send your CV to [email protected] or call 0118 959 4990 for a confidential discussion.