Senior Pharmacovigilance Manager

Senior Pharmacovigilance Manager focuses on review of dossier and printouts (spc/pi) for the parts pertaining to pharmacovigilance, in collaboration with the global regulatory affairs department.

What the role involves

• Review of Dossier and Printouts (SPC/PI) for the parts pertaining to Pharmacovigilance, in collaboration with the Global Regulatory Affairs department.
• Ensure adherence to established and updated local and global processes as well as national and international regulations and guidelines for activities linked with his/her scope.

Skills and requirements

• Essential Duties and Responsibilities for this Senior Pharmacovigilance Manager role include, but are not limited to, the following.
• Master’s degree in life sciences field.
• 8+ years of experience drug safety and pharmacovigilance in the pharmaceutical industry.
• Experience in participating in Audits and Inspections.

Candidate fit

• Supporting both the EU QPPV and the PV Medical Unit, in all phases of the signal management process, from their detection to their communication, including the management of the id.

Additional role context

• Our client, a global biopharmaceutical company with plants across Europe and North America is looking for a Senior Pharmacovigilance Manager to join their team in the UK.
• This is your chance to be part of one of the top players in the field of plasma-derived products, supplying high-quality medicines treating rare diseases, across the globe.
• Ensures proper management of worldwide/national literature research in order to detect meaningful safety data.