|Closing date||3 January 2020|
A bit about us
Regulis is a specialist consultancy company, providing global Pharmacovigilance, Regulatory Affairs and Quality Assurance services. The company was formed in 2001 and since then has seen significant growth. The company is built around a growing permanent team based in Hertfordshire, UK supplemented by an established network of consultants to deliver high quality, customer-focussed solutions.
Our clients range from large multinationals to small start-up companies, from innovators to generic companies.
About the role
The Senior Pharmacovigilance Executive holds an important position within the company and specifically, the Pharmacovigilance team. This role offers the opportunity to act with a significant degree of independence to fulfil and execute a variety of project responsibilities. Working closely with and providing support to the Pharmacovigilance Manager you will ensure that Pharmacovigilance requirements for clinical trials and post-marketing are being adhered to.
This is an excellent opportunity for an independent, self-motivated and driven Pharmacovigilance professional to join a company that will not only provide you with a wide variety of experience in Pharmacovigilance projects, it will also give you all the support you need to grow and develop in the role. If you are looking to progress into a line management role in the future, as the team grows there may be an opportunity for the right person to assume this responsibility, supported by the PV Manager.
- The successful candidate will be responsible for and gain exposure to many different aspects of Pharmacovigilance.
- Represent the Pharmacovigilance department to clients, other third parties and internally within the company.
- To be the key contact and project manage our clients providing metrics, plans and supporting the team in delivering the client’s requirements.
- Review, analyse and interpret safety data authoring and/or providing input to safety-related documents, such as periodic reports.
- Ensure the agreed activities and timelines are met and compliant with the regulations.
- Play a significant role in helping the department grow.
- Provide technical advice and guidance to clients and colleagues as required.
- Life sciences or Pharmacy Degree/Nursing qualification – degree level
- Significant previous PV experience in a Pharma Company or CRO Safety Department, either Clinical Trial Safety or Post-Marketing Pharmacovigilance
- Experience with Safety Databases (ARISg) and ICSR data entry, QC and running aggregate reports
- Familiarity and understanding of current EU PV regulations – US/FDA regulations and requirements would be an advantage
- Experience of E2B electronic reporting would also be an advantage.
To succeed in this role, you should be able to demonstrate proven project management skills, excellent written and verbal communication skills, good organisational and analytical skills, a proactive approach, be able to work quickly and effectively under pressure, and be an outstanding team player. The successful candidate will also be fluent in written and spoken English.
What we offer
- A competitive salary (depending on experience)
- Benefits that include 25 days’ holiday, company pension scheme, life assurance, the option to buy or sell additional holiday, fresh fruit delivered weekly, one day a week working from home, an early finish on Fridays and an annual bonus and salary review
- Ongoing training and personal development support
- The chance to be part of a TOPRA award winning consultancy that will help you to grow and build on your current experience aligning your career goals and aspirations with that of the company
- A strong team ethic with regular events organised
- Modern refurbished office in a town centre location with parking facilities.
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