Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Deputy EU Qualified Person for Pharmacovigilance

Company: Thornshaw Recruitment
Location:
Reference: TD9568
Closing Date: 21 Dec 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

On behalf of our client, a global pharmaceutical company we are working with them on the role of Deputy EU Qualified Person for Pharmacovigilance.

Requirements:

On behalf of our client, a global pharmaceutical company we are working with them on the role of Deputy EU Qualified Person for Pharmacovigilance.


Overview of Responsibilities:
• Responsibility for establishment and maintenance of the Company’s pharmacovigilance system and the Pharmacovigilance System Master File (PSMF). 
• Responsibility for the implementation of changes to the Pharmacovigilance system.
• Promote, maintain and improve compliance with all legal requirements for pharmacovigilance
• Early awareness of new product acquisitions or portfolio expansions as early as possible in order to assess the potential impact on the pharmacovigilance system. The QPPV should also provide input into what pharmacovigilance data should be requested from the other company, either pre- or post-acquisition.
• Oversight of the quality system of the pharmacovigilance system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
• Oversight of the validation status of the Company safety database, including any failures that occurred during validation and the corrective actions that have been taken to address the failures.
• Awareness of scheduled pharmacovigilance audits and enable the triggering of Pharmacovigilance audits where appropriate.
• An overview of medicinal product safety profiles and any emerging safety concerns; 
Education & Experience
• Excellent Organisational and Technical Skills
• Ability to interact readily, establishing credibility and trust quickly.
• Sense of urgency – responding to issues and opportunities in a timely manner 
• Take ownership and accountability for activities
• Positive and pro-active approach to business tasks
• Ability to apply critical thinking and problem solving
• Positive ‘can – do’ attitude
• Excellent organisational and analytical skills. 
• Self-motivated.
• Excellent interpersonal and communication skills.
• Excellent time management skills
• Enthusiasm and Drive to take complete ownership and drive process improvement initiatives. 

For full details please contact Tina at +353 1 2784671 or email your CV in confidence to tdunne@thornshaw.co

Apply for this job: Deputy EU Qualified Person for Pharmacovigilance

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.