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Job Ref.: 1644

Job Title: Qualified Person for Pharmacovigilance (QPPV) – Pharmaceutical Consultancy – Dublin based – August 2018 – Immediate vacancy

Posted Date: 20/08/2018

Sector: Qualified Person (QP)

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Qualified Person for Pharmacovigilance (QPPV) – Pharmaceutical Consultancy – Dublin based – August 2018 – Immediate vacancy

Our client is a well-established pharmaceutical consultancy company based in the UK.  The company currently operates from two sites in the UK. The company offers a wide range of services including all aspects of regulatory affairs, quality, development, pharmacovigilance, medical information and market access services among other allied offerings.

Following the UK’s decision to exit the European Union, our client has now established an Irish registered sister company. Although, this company was only established at the beginning of 2018, it already holds some approved Irish Marketing Authorisations for medicinal products.

They are now looking to recruit a Qualified Person for Pharmacovigilance (QPPV) to work out of their new Dublin offices. The position is a full time permanent role.

Purpose of Job

• Act as EEA QPPV to meet all QPPV responsibilities (as defined in current EU Directive 2001/83/EC, GVP Modules I and II)

Qualifications and Role Requirements

• Life science degree, preferably within the sphere of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.

• A minimum of 5 years pharmaceutical industry experience

• The QPPV shall reside and operate in the EEA

Attributes

• The QPPV should have skills for the management of pharmacovigilance systems

• Ability to work cross functionally within the Company and practically apply pharmacovigilance and associated legislation

• Ability to support senior management by ensuring pharmacovigilance and quality mechanisms are in place to meet regulatory compliance

Limits of Role

If the post holder is not a qualified medical expert the MAH / employer will provide access to expertise in relevant areas such as medicine, and pharmaceutical sciences for the expedition of duties

Main Duties and Responsibilities

A brief summary the EEA QPPV role is provided below:

Overview of safety

• To have an overview of medicinal product safety profiles and any emerging safety concerns

• Have an awareness of any conditions or obligations adopted as part of the MAs and other commitments relating to safety or the safe use of the product.

Risk management plans

• Have an awareness of risk minimisation measures

• Be aware and have sufficient authority over the content of risk management plans

• Be involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU

• Have an awareness of post-authorisation safety studies requested by a competent authority including the results of such studies;

Conduct of Pharmacovigilance

• Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP;

• Ensure the necessary quality including correctness and completeness of pharmacovigilance data submitted to the competent authority

• Ensure a full and prompt response to any request from the competent authorities in the member states and EMA

• Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)

• Act as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections

Operational responsibilities

• Ensure establishment and oversight management of the company’s pharmacovigilance system in all relevant aspects including: o Quality system

o Standard Operating Procedures

o Contractual arrangements: 3rd party licences, distributors, outsource arrangements, service providers, commercial and technical partners

o Database operations: be made aware of the validation status of the database, including any failures that occurred during validation and the corrective actions that have been taken to address the failures

o Compliance data: internal and external data

o Audit reports

o Training of personnel in pharmacovigilance

Quality system

• have sufficient authority to influence the quality system and pharmacovigilance activities across the Company.

• Have oversight of the information contained in the pharmacovigilance system master file (PSMF); to ensure it is an accurate and up-to-date reflection of the Company’s pharmacovigilance system and pharmacovigilance metrics are recorded appropriately.

• Conduct and lead Pharmacovigilance audits when applicable

Delegation of duties

• delegate specific tasks, to appropriately qualified and trained individuals

Local QPPV role

• Act as national QPPV to support wider European registration procedures

An excellent salary plus strong benefits package will be offered to the successful candidate.

For further information, please call Paul Flanagan at +353 1 805 5522 or email your c/v in the strictest confidence to paul@pharmasolutions.ie

NB - Your application and details are treated in the strictest confidence by us at all times.  We comply fully with GDPR guidelines (May 2018). Please see our privacy policy on www.pharmasolutions.ie

Also, please see the full range of our job listings on the Pharma Solutions website which is updated daily

 

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