On behalf of my client, we have a new opportunity for a Deputy QPPV for their Dublin office. This is a full-time permanent role reporting directly to the QPPV based in the UK. Pharmacovigilance/QPPV Main Duties and Responsibilities:
- Extensive knowledge in Pharmacovigilance (PV) and the requirements of GVP and volume 9B.
- Assist the QPPV in maintaining the Pharmacovigilance systems in line with the requirements for human and veterinary pharmaceutical products.
- Assist the QPPV in maintaining an overview of the safety profiles of the company’s medicinal products and any emerging safety concerns.
- In the absence of the QPPV, act as the single point of contact for PV on a 24-hour basis in the EEA for Competent Authorities for PV related matters
- Respond to requests for information from the Competent Authorities relating to the safety profile of the company products or PV activities.
- Assist the QPPV in maintaining the Pharmacovigilance System Master File (PSMF) and the Detailed Description of the Pharmacovigilance System (DDPS) for human and veterinary products, respectively.
- Prepare Adverse Drug Reaction (ADR) reports and expedite reports to Competent Authority when required.
- Conduct periodic ICSR reconciliation with business partners.
- Generation and management of aggregate reports such as line listings and summary tabulations
- Signal management activities including signal detection and validation.
- Compile and present signal detection and periodic PV reports
- Monitor literature searches and maintain the literature monitoring tracking system.
- Prepare annual schedule for Periodic Safety Update Reports (PSURs)
- Receive and process Medical Information enquiries from healthcare professionals and the public.
- Provide up-to-date and relevant medical and technical information in response to the enquiries.
- Maintain the medical information trackers for human and veterinary medical products.
- Graduate (or equivalent) in Life sciences in a relevant area (ideally 2:1 or above)
- 5 years’ experience in Pharmacovigilance
- Previous experience within Medical Information
- QPPV or deputy QPPV – registered with the competent authorities.
- Demonstrated planning and organisation skills.
- Ability to work autonomously, effectively, and collaboratively.
- Excellent interpersonal and negotiation skills (internal/external)
Thornshaw Scientific is a division of the CPL group.
2 weeks ago
On behalf of my client, a global medical and pharmaceutical device company located in Dublin we are currently recruiting for a Product Complaints Coordinator. Reporting to the Regulatory Affairs Manager you will have the following responsibilities. Role & Responsibilities:
- Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company’s Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures.
- Document and maintain the complaint files for all reports received.
- Prompt communication of every complaint received to the Global Complaints Department and escalation of serious product complaint issues, as necessary, to the relevant people both locally and globally, within the required timeframes.
- Liaise with customers, in collaboration with the Sales/Marketing teams, regarding product quality issues and also in relation to medical/technical/clinical queries, ensuring an accurate and prompt response.
- Review the product complaint investigation reports and document letters for the customers to relay the investigation results.
- Provide periodic training, as required, to all relevant personnel on the handling of product quality complaints.
- Contribute to the documentation and review of local procedures for product quality complaints.
- Attend and partake in internal and external audits related to your job.
- Support Pharmacovigilance, Medicovigilance and Compliance activities as directed when required.
- A degree in a life science or pharmacy discipline.
- 2 years work experience in a compliance environment and a good understanding and working knowledge of GxP.
- Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and the EU.
- Proficiency in the English language with strong verbal and written communication skills is essential.
- Ability to process technical information.
- Accuracy and excellent attention to detail.
- Excellent organisational skills.
- Good interpersonal skills.
- Computer skills (Microsoft Word, Excel; SAP an advantage).
2 weeks ago
On behalf of my client, I am recruiting for a Continuous Improvement & R&D Scientist. This position will be largely project based and will entail a high degree of autonomy and initiative. This is an 18 month contract position. Key Responsibilities:
- Conduct scientific studies. Analyze data and processes; develop, characterise and make formal recommendations.
- Plan and execute experiments using design of experiment techniques
- Coordinate and assist the formal creation of system test methods in conjunction with the Quality and Regulatory Groups
- Reengineer existing processes or test methods to adapt to changes in market, business, and/or regulatory requirements.
- Transition products and processes from development phase to routine production
- Work within cross functional teams to identify key project/process or performance attributes and opportunities for product and process improvements.
- Coordinate and lead technical root cause investigations.
- Cooperate with other functional areas and groups within the company to achieve robust product supply
- Participate in Product transfer activities within the company
- As required lead reagent & system complaint investigations within the company and subsequent report handling.
- Adherence to the quality system and training given at all times
- Completion and review of Documentation to cGMP/GDP requirements/standards.
- Work constructively with team members from R&D, Continuous Product Improvement, Marketing, Operations, Quality Assurance, Technical Support, Clinical Affairs, Customer Service, and Finance.
- Work constructively with team members from the company on multi-site projects
- Communicate progress on a frequent basis. Communication will require the successful candidate to present project updates to the relevant stakeholders
- An advanced life science degree.
- Laboratory experience in biological sciences required
- Demonstrated competence in biochemical techniques and statistical concepts.
- Experience in the field of Coagulation/ IVD industrial of ≥2 years would be advantageous.
- Ability to read, analyze, and interpret technical data, and technical procedures.
- Excellent attention to detail and the ability to work well alone and as part of a team.
3 weeks ago
Role DescriptionOn behalf of our client, a global pharmaceutical company, we are actively recruiting for the role of Project QA for their Global Product Supply division. My client is in the process of creating a new quality project organization in Global Quality. This organisation will be responsible for all the GPS projects that are driven or supported by Global Quality. Roles & Responsibilities: You will work closely with the project organisation and stakeholders to ensure that quality standards are implemented in each initiated project, ensuring effective communication and alignment on deliverables and timeliness. Your primary responsibilities will be: Supporting SME /QA, representing Global Quality in GPS projects. Ensure that quality standards are implemented in projects Assure ongoing compliance with quality and industry regulatory requirements You will in a global team and be in contact with numerous people in multiple departments and functions. Qualifications & Experience required for this role: Relevant 3rd level qualification in science discipline Master degree preferred but not essential Certifications are an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma, quality inspection, auditing and testing experience You should have several years of experience within the pharmaceutical industry and extensive experience with GxP/Quality. You are a self-starting and highly structured person who can get Quality on the agenda and deliver great results on time. Working cross-organisational takes effective communication and collaboration skills in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions. Excellent communication skills - verbal and written QA project experience Experience with implementation of corrective action programs For full spec and information email your CV to [email protected] or call Tina at +01 2784701
3 years ago