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Job Details

EU QPPV & Safety Physician *Flexible Location Throughout Europe*

Company: Advanced Clinical Recruitment Ltd
Reference: EUQPPV, Safety Physcain
Closing Date: 03 Feb 17
Type: Full Time
Salary (£): Competitive

Job Summary:

Brief Description: This position requires involvement in all facets of drug safety management, including the medical review and evaluation of serious events and establishing causality assessments. In addition, this position is also responsible for establishing and maintaining the Market Authorisation Holder’s (MAH, Client) Pharmacovigilance System, overseeing the safety profiles of the client’s marketed products in the EU and acting as a single point of contact for the Regulatory Authorities.


Specific Job Duties:
-Establish and maintain/manage the MAH’s PV system to ensure full compliance with all legal and regulatory requirements in the EU

-Have an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the MAH holds authorizations in EU

-Act as the main point of contact with the relevant competent authorities and being available to be contacted by them 24/7

-Having an oversight of the PV system and delegates tasks and maintaining ultimate responsibility on them,  including: oversight on Individual case safety reports (ICSRs), Standards Operating Procedures (SOPs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), Post Authorization Safety Study (PASS) protocols, Risk Minimisation Strategies, effectiveness of follow-up measures, of post-marketing commitments, on safety database, on e-transmission and on important observations from QA audits of PV activities

-Provide continuous monitoring of safety profiles of MAH’s medicinal products

-Keep up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology

-Ensure full compliance of the MAH’s PV system with the European regulations

-Lead the preparation of aggregate safety reports (PSURs, DSURs, RMPs, safety issue workups etc), thus contributing to high quality standard documents within the organization

-Coach more junior physicians and scientists with regards to safety writing or safety processes

-Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write/review the narrative, confirm seriousness rating and causality and expectedness assessment

-Perform medical review of ICSRs

-Perform  signal/trend detection management activities

-Evaluate laboratory values for potential SAEs

-Review SAE and AE coding to ensure medical accuracy with the verbatim reported term

-Participate in Quality Check activities

-Support regulatory inspections and actively participate to their preparation

-Prepare and review internal UBC SOPs and project specific procedures

Supervisory Responsibilities:
-Mentoring and training on safety activities of related staff

-Strong experience in pharmacovigilance (8+ years) in Pharmaceutical Companies, biotech or CRO

-Excellent knowledge of EU pharmacovigilance regulation and legislation

-Deep knowledge in other aspects of product development and post marketing product management (regulatory, quality assurance, risk management, benefit risk, epidemiology, medical affairs)

-Medically qualified Doctor preferred but not essential

-Strong expertise in medical safety writing

-Experience in writing SOPs

-Fluent in English; additional languages a plus, but not required

-Excellent written and verbal communication skills

Apply for this job: EU QPPV & Safety Physician *Flexible Location Throughout Europe*

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
S11 8NX
Tel:  0114 270 1741
Website:  Visit Our Web Site

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