QPPV – Veterinary
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.
Building on over 35 years of research and development, with over 4,500 licenses registered worldwide, Chanelle Pharma is headquartered on an 18-acre campus in Loughrea, Co Galway, with three manufacturing facilities, four research and development laboratories and a fifth R&D laboratory in Jordan. The company employs 550 people in Ireland, UK, Jordan and India. At Chanelle Pharma our employees drive our success and you will have the opportunity to collaborate in our diverse and inclusive environment, the ability to learn and grow in your career, and an opportunity to make a direct impact on our business and customers.
Chanelle Pharma has a proven track record of innovation and makes a significant investment in R&D annually and has doubled its sales growth in the last 5 years.
In 2018, the company announced an €85 million investment, the single largest investment by any Irish owned company, to double manufacturing capacity, launch 96 new products and grow its workforce to 850 people over a period of 5 years. As part of the investment, Chanelle opened a purpose built €10 million manufacturing facility in 2018 for the company’s expansion plans into the US market. The facility received FDA approval in September 2019.
Chanelle Pharma is on an ambitious growth trajectory and expanding its workforce across a number of disciplines in science, engineering, quality, finance, sales and marketing. The company won 2018 Pharma Company of the Year and Industry Company of Year, the first indigenous Irish company to win the award.
This is an opportunity to be part of a dynamic team within the Vet Regulatory Affairs function. 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.
To act as the qualified person for pharmacovigilance (QPPV) for veterinary products.
- Maintaining Chanelle’s veterinary pharmacovigilance system
- Conducting continuous overall pharmacovigilance evaluation during the post authorisation period of products
- Managing of the provision to the NCAs or the Agency of any other information relevant to the evaluation of the benefits and risks of a VMP
- Managing the Logging, investigating and reporting of Pharmacovigilance complaints received
- Managing the Preparation of Periodic Safety Update Reports for submission to Regulatory authorities in relation to national, MRP, DCP and centrally approved Marketing Authorisations
- Managing the submission of expedited reports when necessary
- Managing the maintenance of Pharmacovigilance systems (CRF’s PSUR data base, Line Listings)
- Collation of Pharmacovigilance data received from sub licensees
- Provision of Pharmacovigilance data to sub licensees
- Handling of requests for information from competent authorities,
- Handling of urgent safety restrictions and Submission of safety variations
- Remain informed with current pharmacovigilance requirements.
- Reviewing pharmacovigilance sections in Contracts and Agreements with third parties
- Identifying training needs for pharmacovigilance and implementing appropriate training plan.
- Oversight of quality control and assurance procedures within the pharmacovigilance system
- Oversight of SOPs within the pharmacovigilance system
- Oversight of compliance data in relation to the quality, completeness and timelines for expedited reporting and submission of PSURs within the pharmacovigilance system
- Oversight of pharmacovigilance audit reports
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
- Ability to build relationships and collaborate with others is vital.
- A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
- Proven people management capabilities. Ability to motivate a team and collaborate cross-functional and across geographies
- Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
- Positive and proactive person who is energised by having great responsibility
- Practical, action-orientated approach to managing priorities and teams.
- The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
- Strong computer skills in MS Office
The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
- Scientific qualification and background preferably B.Sc. or equivalent.
- Minimum 5 years in a FDA/CVM regulatory/R&D environment preferably with experience of pharmacovigilance. Knowledge of EU pharmacovigilance would be an advantage.
- Experience in busy problem solving environment with the ability to work to tight deadlines and on one’s own initiative.
- Detailed technical knowledge of products and processes.
- Strong Customer Service focus both internally and externally
- Good command of technical English (both written and spoken)
- Ability to work on multiple projects simultaneously.
- Communication skills with external and internal customers.