Cache of job #13698540

Job Title

Pharmacovigilance Officer

Employer

Matrix Recruitment

Location

Galway, Westmeath

Description

What you need to know. Matrix Recruitment are looking to recruit a Pharmacovigilance Officer for their client a leading Pharmaceutical company the Midlands / West Region. Permanent position - responsible for carrying out pharmacovigilance activities in accordance with Good Pharmacovigilance Practices and company Quality Management Systems. Your new job. Evaluate adverse event reports received directly from regulatory authorities and input relevant reports onto an internal database. Process safety data arising from all source as per SOPs. Inputs onto Medicinal Product Dictionary. Prepare and ensure submission of PSURs and Risk Management Plans in a timely manner. Update Pharmacovigilance System Master File as required. Ensure identified safety variations are planned, tracked and sent as per set timelines in accordance with the legislation. Respond to medical information queries. Respond to queries form regulatory authorities. Liaise with the Regulatory Department to ensure label updates arising from Pharmacovigilance activities are implemented in a timely fashion. Prepare weekly reports for the Regulatory Manager and QPPV. Ensure compliance with Volume 9A of The Rules Governing Medicinal Products in the EU and GVP modules, Reg 1235/2010, Reg 520/2012 and directive 2010/84/EU as applicable, and also the company procedures. Identify and implement practices to improve the Pharmacovigilance system including review of SOPs as required. what are we looking for? Educated to degree level in science or relevant discipline. Previous experience in a busy fast paced environment. Excellent communication skills with strong attention to detail. Ability to work on own initiative and meet strict deadlines. Salary €30,000. Apply for this job now or get in touch with Marguerite on 09064 90485. Matrix Recruitment Group is committed to providing a professional service where all CV's are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent. This job originally appeared on RecruitIreland.com.

Date Added

2562 days ago

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