Deputy QPPV manager

Use your extensive industry experience to help with the operational management of internal processes, design and implementation PV/drug safety systems for clients and project manage for a global CRO.

Rate Negotiable Industry Life Sciences Location France Type Contract Ref JO-1612-899408 Posted 156 days ago

Job Description

Deputy QPPV -Permanent Contract- France   
 

Level: Deputy QPPV   
Contract: Permanent 
Salary: Negotiable
Location: France, EU
Duration: Permanent Contract  
 
Summary 
 
We are looking for a Deputy QPPV manager with extensive industry experience to join a global CRO. The successful candidate will act as a local contact person for France and they must be fluent in French and English.
 
Responsibilities 

  • Experience with post-market pharmacovigilance in a CRO environment
  • Qualified to act as Local QPPV or Deputy Local QPPV for France
  • Project management experience on drug safety and pharmacovigilance
  • Operational management of internal processes of internal project teams and external communications with clients
  • Design and implementation PV/drug safety systems for clients
  • Involvement in coordination/preparation/review of Safety Management Plans
  • Coordination of EudraVigilance registration of Sponsors/MAHs in Europe
  • Participation in collection and management of SAEs and/or Spontaneous Reports process
  • Involvement in quality control activities
  • Preparation/review/coordination of submission of DSURs/PSURs or other periodic reports
  • Manage relationships between affiliate teams and global teams
  • Ensure clearly defined PV responsibilities, and provide support on maintaining PV systems on affiliate sites
  • Ensure appropriate local PV SOP’s
  • Coordinate PV training and actively contribute to resource allocation as required
  • Keeping ahead of local PV legislation and informing the Global PV team as soon as changes occur
  • Collaborate with local drug safety officer to manage audits and inspections including CAPA management
 
Education:
  • Minimum of 5 years’ experience in PV (post-marketing experience in CRO environment)
  • Degree in relevant subject (Pharmacist or Medical Doctor)
  • Knowledge of PV regulations for France
  • Excellent written/ oral communication skills
  • Accuracy and attention to detail
  • Project management experience
  • Fluent in French and English
 
This is a permanent contract. #LI-AT1 #LI-15

Amie Touray Consultant

"Consultant in Life Science, part of the Regulatory affairs team. Specifically dealing with CMC professionals across Europe."

+44 (0)20 7002 0000 Get in touch

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