Qualified Person for Pharmacovigilance

Qualified Person for Pharmacovigilance (QPPV)

On behalf of our client, we are currently recruiting for a Qualified Person for Pharmacovigilance (QPPV). This person can be predominantly remote with occasional travel to Irish office.

Purpose of Job

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

Attributes

· The EEA QPPV should have skills for the management of pharmacovigilance systems.

· Ability to work cross-functionally with all company departments and clients 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.

Relevant Regulation and Related Issue

· Directive 2001/83/EC

· Regulation (EC) No 726/2004

· Regulation (EC) No 520/2012

· Commission Implementing Regulation on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC

· Guideline on good pharmacovigilance practices modules

· Chapter 3. II: XEVMPRM User Guidance: Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation 9EC) No. 726/2004 EMA/135580/2012

· Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority.

· Data Protection legislation.

· Any further relevant EU statute

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 EEA QPPV shall reside and operate in the EEA.

Limits of Role

The post holder is not expected to authorise expenditure. If required, this will be in agreement with the Associate Director, Pharmacovigilance.

Main Duties and Responsibilities

The EEA QPPV is responsible for the functions described below and, where appropriate, in the client-specific job description.

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 client MAs and other commitments relating to safety or the safe use of the product.

· Ensure that signal management activities are conducted appropriately.

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 EEA or pursuant to a risk management plan agreed in the EEA.

· Have an awareness of post-authorisation safety studies requested by an EEA competent authority including the results of such studies.

Conduct of Pharmacovigilance

· Ensuring conduct of pharmacovigilance and submission of all EEA pharmacovigilance-related documents are in accordance with the legal requirements and GVP.

· Ensure the necessary quality including correctness and completeness of pharmacovigilance data submitted to the EEA competent authority.

· Ensure a full and prompt response to any request from the competent authorities in the EEA 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 EEA Member States and EMA 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:

· Quality system;

· Standard Operating Procedures;

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

· 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;

· Compliance data: internal and external data;

· Audit reports;

· 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 for clients and partners and respond to any deficiencies in conjunction with the MAH ensuring correct CAPAs are applied and completed.

Delegation of duties

· Delegate specific tasks, to appropriately qualified and trained individuals.

Local QPPV role

· Act as National QPPV to support the client EEA QPPV in management of pharmacovigilance activities in Ireland.

General Responsibilities

· Support the company and clients in pharmacovigilance meetings with authorities and or other relevant meetings.

· Mentoring and training of new and existing employees as required on Pharmacovigilance To act as a source of pharmacovigilance expertise for the Company.

· All employees of have a responsibility under the Health and Safety at Work etc Act 1974 to ensure their own and other’s safety whilst at work and to be aware and work within the framework of company Health and Safety Policy and the associated Standard Operating Procedures.

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 EEA QPPV shall reside and operate in the EEA.

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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