|Closing date||9 August 2019|
A bit about us
Regulis is a specialist consultancy company providing global Regulatory Affairs, Pharmacovigilance 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 global network of consultants to deliver high quality, customer-focused solutions.
Our clients range from large multinationals to small start-up companies, from innovators to generic companies.
About the role
This position provides a stimulating, exciting and unique opportunity to the right person. You will be managing a portfolio of clients and a range of projects working to often tight deadlines. You will be expected to apply your pharmacovigilance know-how and experience by working independently to take the lead on some of our more interesting and challenging projects. Working closely with and providing support to the EU QPPV and Drug Safety Physician, you will ensure that pharmacovigilance requirements for clinical trials and post-marketing are being adhered to.
This could be your first step into a team management position or if you already have some supervisory/mentoring or management experience that’s good as you’ll have a foundation to build on. You will also have the opportunity to play a part in helping to grow the business by creating proposals, attending bid defence meetings and building strong relationships with new clients or maintaining relationships with existing clients.
You will work directly with clients, managing the contractual and financial elements of projects with a significant degree of autonomy and independence. You will interact professionally at multiple levels within client organisations and with other stakeholders.
The position requires between 5-7 years’ pharmacovigilance experience, both in post-marketing and clinical trials activities.
You will need to have proven experience of the following:
- Safety databases
- ICSR data entry management and aggregate reports
- Safety Management Plan and Risk Management Plan writing
- Familiarity and understanding of current EU pharmacovigilance regulations, as well as US and ROW regulations
- Experience of E2B electronic reporting to Regulatory Authorities
- Understanding of post-marketing and clinical trials pharmacovigilance routine activities.
- Decision making and problem-solving skills as well as critical thinking.
This is an excellent opportunity for a talented, independent and self-motivated pharmacovigilance professional with significant previous pharmacovigilance experience in a Pharma Company or CRO Safety Department.
- An opportunity to combine complex pharmacovigilance project work, financial management of multiple projects simultaneously and line management in one role.
- Motivate, line manage and coordinate a team.
- Forge strong relationships with clients and stakeholders.
- Be part of a small, high performing team
- Take responsibility for a wide range of projects.
The opportunity to play a part in growing and enhancing the strong reputation the company already has in the pharmacovigilance industry.
- Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification
- Between 5-7 years’ experience in the area of pharmacovigilance.
To succeed in this role you will require strong 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 (related to 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
- Ongoing training and personal development support
- The chance to be part of an 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 newly refurbished office in a town centre location with parking
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