Our client, a global pharmaceutical company are currently recruiting for a Pharmacovigilance Associate
To ensure the following:
• Provide technical and process-related support to drug safety management and scientific activities, ensuring compliance with relevant regulations and procedures.
• Perform initial triage of received safety notifications and adverse event case reports
• The management of adverse event case reports from receipt to closure, perform verification of safety data to ensure validity and utilize Pharmacovigilance (PV) judgment in coding of serious/non-serious events and synthesising complex clinical information into accurate and complete narratives.
• Ensuring complete case compilation by acquisition of all relevant adverse event information, data entry, data review, duality review and maintenance of case reports in the safety database (ARISg) in accordance with APTL standard operating procedures (SOPs) and regulatory requirements.
• Distribution of e-mails and incitation of telephone calls to partners, healthcare professionals and/or consumers in the attempt to retrieve follow-up information when required for ICSR processing, using a communication module in line with company SOP.
• Regulatory reporting of ICSRs to health authorities, affiliates and partner(s), ensuring complete documentation and tracking of each submission.
• Ensuring good documentation practices.
• Reconciliation of all adverse event reports from PV service providers, distributors and licence partners.
• Perform world-wide literature review for assigned product(s) to identify potential ICSRs and to identify safety information in accordance with company SOP’s.
• Updating and maintaining Endnote Literature Library in accordance with literature search results
• Participating in regular operational Pharmacovigilance team meetings.
• Assist with Data Entry, Data Review and maintenance of the Medical Product Dictionary (MPD) and Company Product Dictionary (CPD).
• Managing multiple departmental email inboxes and any issues that may arise.
• Maintain awareness of Pharmacovigilance regulatory requirements and developments.
• Contribute to agreed PV team compliance targets.
• MedDRA Coding and drug coding.
• To review AE listings to identify data issues and safety trends as required.
• Support aggregate report write-up, as required.
• Support preparation of SOPs, product safety reviews, as required.
• Support the continuous development and improvement of the Pharmacovigilance department.
• Work effectively and efficiently.
• Priorities and management of individual workload to ensure regulatory, internal and business partner timelines are adhered to.
• Strive to uphold core values.
• Adherence to company Health & Safety procedures.
• Participate in training programs, webinars and conferences.
• Any other duties as assigned by manager or QPPV, as required by the business needs.
• Adhere to agreed Key Performance Indicators (KPIs).
• Maintain MedDRA competency by completing the coding examination.
• Comprise Pharmacovigilance training material when required.
Qualifications and Experience:
• Life sciences/biological sciences graduate.
• Min 1 year experience in Pharmacovigilance.
• Competent medical terminology.
• Excellent communication and IT skills.
• Previous use of ARISg database is desirable.
For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671