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Job Details

Head of Pharmacovigilance

Company: Planet Pharma Staffing Limited
Location: Brussels, Belgium
Reference: SCPVHEAD
Closing Date: 25 Feb 18
Type: Permanent
Salary (£): 80,000 - 100,000
Benefits: Attractive

Job Summary:

I am currently recruiting on behalf of a US Biotech for the position of 'Head of Pharmacovigilance'. You will be leading the PV department working from their Belgian office and be involved in innovative early phase Oncology studies with operational duties. Please read on for more information...

Requirements:

Overview

• Responsible for managing internal (long term vision) and external staff allocated to operational PV activities, creating a highly efficient team across outsourced resources.

• Contribute to the development of global Medical Safety/Pharmacovigilance strategies

• Implement a pharmacovigilance system fully compliant with the applicable worldwide Health Authority PV regulations.  

• Contribute to the selection of PV vendors to support an outsourced PV business model. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics. 


• Establish a system for prevention and correction of deviation to compliance with internal and external stakeholders

• Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.

• Develop and/or maintain a set of safety SOPs related to the processing and reporting of SAEs from clinical trials and marketed products to ensure performant and compliant PV processing, integrated with other PV and non-PV SOPs.

• Contributes to the signal detection, benefit-risk profile assessment and aggregate reporting activities.

• Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversees timely submissions of expedited reports to the FDA & other health authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.

• Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.

• Ensures specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant PV Vendor.

• Represents drug safety as a leader on project teams, other departments.

 

Qualifications & Experience 


• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience, advanced Life Sciences Degree  

• Minimum of 5-7 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry; minimum 3 years in managerial role in drug safety

• Experience in oncology (I/O) preferred

• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources

• Through knowledge and experience in all aspects of safety reporting for clinical trials

• Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.

• Operational expertise with ARGUS preferred.

• Level will be commensurate upon experience and qualifications 
 

Salary/Package

Attractive basic salary + benefits including car allowance

About Planet Pharma 
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sam Chapple on +44 (0)20 3868 8607 or e-mail on schapple@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Keywords 

Pharmacovigilance, pv, head, manager, Belgium, pharmaceutical, oncology, biotech

Apply for this job: Head of Pharmacovigilance

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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