My Client is a specialist consultancy within the field of Regulatory Affairs and Drug Safety.
Has opened a new vacancy within the Pharmacovigilance team. They are looking to add a QPPV to be based at either there London or Paris Office
· Pre- and Post-Market safety cases medical assessment
· Case narrative review
· MedDRA coding
· Interactions with the necessary Regulatory Authorities
· Risk Management Plans
· Pharmacovigilance System Master File's preparation
· Periodic Safety Report review
· Provide medical expertise on assigned projects where needed
· Represent the business at relevant conferences within Europe to support business growth
· You will need to have experience in Pharmacovigilance at a senior level and also have experience in a QPPV role.
· Medically qualified Doctor
· 8 years experience within pharmacovigilance working with either a Pharmaceutical, Consultancy or Biotech business
· Experience in writing RMPs
· Expert knowledge of EU pharmacovigilance regulations
· Experience in writing SOPs
· Knowledge of regulatory requirements in other regulatory regions including the USA or Asia
· Experience handling inspections and audits
More information available on request.
For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070