Do you want to be part of a fantastic growth journey where you play a key role in executing the strategy? We are a young, dynamic company with focus on offering prescription specialty and branded pharmaceuticals in the Scandinavian markets. We are scaling for growth and have an increasing portfolio. This is a role where you will have direct influence on the business, be in close contact with partners, out-sourcing specialists, and internal functions. You will be responsible as Deputy QPPV and support the QPPV as head of Pharmacovigilance Operations.
The Deputy QPPV must reside in Sweden and should be permanently and continuously at the disposal of the MAH / company.
Establishing and maintaining a pharmacovigilance system
Review and update pharmacovigilance system master file (PSMF) to ensure is an accurate and up-to-date reflection of Company PV system.
Preparing pharmacovigilance reports as defined by regulations
Answering requests from Health Authorities
Providing Health Authorities with any other information relevant to product safety
Establishing and maintaining/managing the pharmaceutical company's pharmacovigilance system
Having an overview of the safety profiles and any emerging safety concerns for the company's drugs
Represent Drug Safety (DSA) in company projects and collaborate with other departments
Acting as a deputy single contact point for the Health Authorities on a 24-hour basis
The position is a great opportunity to work with Pharmacovigilance and support the growth of a company with focus on processes and systems.
About the job
You will support the QPPV and lead the PV operations to ensure safety compliance and efficient processes. You will be involved in compiling, submitting, and maintaining Risk Management Plans. You are also responsible for answering questions from the authorities in collaboration with manufacturers and with colleagues in other the departments. You are responsible for coordinating matters related to PV and you will ensure that the company is in compliance with the PV regulations and requirements.
Besides building the necessary quality system within PV, you will also ensure that we always are inspection ready and in compliance.
We require you hold a relevant education within natural science (pharmacy, medicine, dental). to qualify as Deputy QPPV. The role should be appropriately qualified with documented experience in international pharmaceutical companies with a minimum of 8 years’ experience in Pharmacovigilance/Drug Safety. Experience in providing medical judgement is an advantage. You will be responsible for managing an external partner with employees in India – and experience from working in India or with Indian companies is an asset. You manage to work detail oriented and hands-on when required and at the same time maintain an overview of the whole and keeping a good structure.
Besides working with PV, you will assist with Quality Assurance and general support with inspections. Experience from working with QA and inspections are required.
We expect that you are fluent in English (written and verbal) – other languages are an asset.
Who are we?
You will join an exciting company with high growth ambitions. We want to make a difference by offering treatment solutions within areas like oncology, rare diseases, and neurology.
You will be part of a growing team, where we treasure a can-do-attitude, solution-oriented thinking, and close collaboration. We work closely together to ensure high performance and the best service to the rest of the organisation. At Newbury Pharmaceuticals, we have an open atmosphere and work as one team to achieve our goals. We are based in Lund, Sweden – and expect you to be regularly in the office combined with the possibility of hybrid-working.
About Newbury Pharmaceuticals
We are a young, dynamic, and ambitious company which has built a solid foundation of internal systems and a strong pipeline. We are now ready to take the next step on our growth journey where we will commercialise a number of medicines and make further advancement of the portfolio by finalising registrations and by adding new in-licensing opportunities.
We offer modern offices in Lund, Sweden and the possibility for hybrid working. We are moving from being a start-up to scaling the business for growth. You will have the opportunity to join this exciting journey.
Applications will be reviewed on a continuous basis and please submit your resume and short motivation at: HR@newburypharma.com