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Job Ref.: 1744

Job Title: Scientific Officer – Pharmaceutical Consultancy – Dublin based – April 2019 – Immediate vacancy

Posted Date: 20/04/2019

Sector: Medical Affairs

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Scientific Officer – Pharmaceutical Consultancy – Dublin based – April 2019 – 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 Scientific Officer to work out of their new Dublin offices. The position is a full-time permanent role.

Purpose of Job

To provide regulatory, pharmacovigilance and quality support services to activities of the business.

To support the Qualified Person for Pharmacovigilance to meet pharmacovigilance obligations as required by law.

To support the Qualified Person to meet quality obligations as required by law.

Qualification and Role Requirement

Life science degree preferable in the sphere of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.

At least 1 year’s Regulatory Affairs experience.

Main Duties and Responsibilities

Pharmacovigilance

To work within the PV team to ensure collaboration, compliance and completion of pharmacovigilance activities in a timely manner.

Identify and assess adverse event reports for processing, determining appropriate prioritisation criteria, in-put into the Drug Safety database and tracking systems and construct a case narrative ensuring compliance with Pharmacovigilance requirements and reporting timelines.

Contribute to data input into European medicine product database according to legislation and company requirements.

Contact Reporter for additional information regarding adverse event reports.

Conduct expedite reporting in accordance with worldwide regulatory agencies and competent Authority requirements as well as company guidelines ensuring data is processed swiftly and appropriately within required timelines.

Review Scientific literature.

Be responsible for liaison with key partners, and other stakeholders/third parties regarding safety data collection and data reconciliation.

Quality

Maintenance of the company’s Quality System in compliance with applicable standards and regulations including risk management document control and pharmacovigilance master file system.

Provide support towards the site management review process.

Review international standards/ regulations to identify gaps in the Quality System and inform management about changes that compromise compliance.

Contribute to the review and approval of master batch manufacturing records.

Contribute to the review and approval of raw material, packaging and finished product specifications and report templates.

Contribute to the review and approval of process validation and equipment qualification documentation.

Completion of annual product quality reviews as per approved procedures.

Liaising with Qualified Person, department managers and Senior Management where required to resolve issues related to quality.

Review of Batch Manufacturing Records prior to Qualified Person review.

Review of Laboratory Data prior to Qualified Person review.

Identify and assess product quality complaints, enter them into tracking systems.

Regulatory

Acts as responsible Regulatory Team member for assigned regulatory projects.

Contribute to the preparation of regulatory submissions and the life cycle management of Marketing Authorisations.

General

Actively participate and employ effective communication practices.

Continuously review processes to improve efficiency and ensure compliance.

Develop and preserve expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, and guidelines relating to the role.

Understand and contribute to the compilation of compliance metrics for Qualified Person and Qualified Person for Pharmacovigilance.

Contribute to all activities prior to, during, and resulting from external inspections and internal/external audits including close-out activities.

Contribute to and support resolution in any required corrective and preventative actions.

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 asap

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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