Pharmacovigilance Compliance Manager
- Employer
- Planet Pharma Staffing Limited
- Location
- Edinburgh, City of Edinburgh (GB)
- Salary
- Competitive Salary in line with skills and experience
- Start date
- 3 Nov 2019
- Closing date
- 3 Dec 2019
View more
- Discipline
- Clinical Research, Drug Safety, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Key Responsibilities
- Manage Global Drug Safety (GDS) compliance and support GDS with CAPA management
- Contribute to the relevant sections and perform QA review of all modules of the PSMF (pharmacovigilance system master file)
- Perform QA review on procedures and working instructions (PSURs, RMPs)
- Perform QA review on GVP procedures
- Develop and maintain QA GVP departmental procedures
- Update and maintain quality incident tracking systems and related QA documentations
- Perform gap analysis as part of inspection / audit preparation or audit of PV system and participate where required
Position Requirements
- Bachelor's degree in life science subject essential
- Extensive experience in pharmacovigilance with proven track record in successful European and/or FDA PV inspections
- GVP, compliance and/or quality system experience
- Experience in CAPA management, GVP process development and training
- Working knowledge of global PV regulations, including EMA, FDA regulations and ICH
Company
Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.
Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.
We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.
- Website
- http://www.planet-pharma.co.uk/
- Telephone
- +44 203 868 1000
- Location
-
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert