Senior Pharmacovigilance Executive
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
This is an opportunity to be part of a dynamic team within the medical Pharmacovigilance functions, working closely with the other relevant functions within the business. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high-quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
• Work closely with the Qualified Person Responsible For Pharmacovigilance (QPPV), deputy QPPV, and other members of the pharmacovigilance team/service providers, to ensure timely, effective, and appropriate processing and evaluation of Safety Data Exchange Agreements (SDEAs), documents and reports necessary to maintain a compliant pharmacovigilance system.
• Contribute to the implementation and improvement of process/system improvements to PV system.
• Liaising with and providing PV guidance & advice on PV topics to all key stakeholders.
• Identify, develop, and roll out opportunities for continuous improvement in the PV system.
• Work with stakeholders to ensure goals of the PV process are achieved.
• Prepare / Review, maintain, and present PV Key Performance Indicators (KPI’s) to management.
• Review and oversee Pharmacovigilance System Master File (PSMF) and associated annexes.
• Review and approval of signal detection reports.
• Participate in the preparation and roll-out of regulatory policies, guidelines, and procedures.
• Attend and participate as a subject matter expert (SME) in PV audits/inspections and meetings, as necessary.
• Monitor company/ co-partner compliance and liaise with management to mitigate identified risks.
• Manage timelines for responses to PV audits, inspections, and queries from all stakeholders and customers.
• Supporting and where requested participate in all PV activities such as EVMPD, Medical Information, etc.
• Assist in the management & oversight of PV variation changes and updates, transfer of PV information to other internal departments, PV SOP, and PV training.
• Participate as PV SME in inter-department PV discussions as required.
• Other ad-hoc duties as requested by Management.
• Projects – from time to time you may be asked to assist in various projects and ad hoc duties.
• Prepare reports and presentations for management as and when required.
• Any other activity as per the manager’s or Department head’s requests.
• Possess strong verbal and written communication skills with excellent attention to detail. Proficiency in Microsoft Office, PowerPoint, Excel, MS PowerPoint, and MS Outlook.
• Be detail and results-oriented, with an ability to multi-task and work in a dynamic, fast-paced environment.
• Highly motivated person who works well under pressure, has excellent organizational abilities, sets and meets deadlines, be able to handle several priorities in a day; is dependable, adaptable, creative, and self-motivated.
• Excellent interpersonal skills required.
The above is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required.
• 3rd level degree in a relevant medical or PV-related discipline.
• Minimum 2 years in a PV environment.
• Strong verbal and written communication skills.
• Strong computer skills in MS Office.
• Experience working as an EU QPPV or deputy EU QPPV work is an advantage but not essential.