Pharmacovigilance Specialist – Pharmacovigilance Services

(Full Remote or Prague / Helsinki-based)

Tepsivo is a young company on an ambitious mission to reshape the world of Pharma and pharmacovigilance into a modern-day industry. Since our conception in 2020, we’ve become the world’s first fully digital global PV provider, with a genuine end-to-end PV system run by our in-house developed tools.

We’re looking for people with solid background in pharmacovigilance operations and who want to make a dent in the PV services industry that has so far been dominated by dinosaurs relying on obsolete business models with low value-added activities and manual labor-intense processes.

It’s high time for a change, and that’s what we’re here to do. Are you?

What is your ideal background?

– Significant experience in ICSR processing all the way from intake to submission
– Solid knowledge on international PV requirements (especially EU)
– Thorough understanding of ICH E2B(R2/R3) standard
– Education in Life Sciences (e.g. pharmacy)
– Professional fluency in English

Just as important – this is a role for people who are very good with computers, believe in streamlining and digitizing old-school processes, and are not afraid to challenge the established practices within industry as well as regulators.

What do we expect you to do?

As a PV specialist, you will be at the forefront of overhauling the PV services industry. You will be responsible for day to day interactions with Tepsivo customers, whatever that may entail.

We expect you to be a quick learner and to have the ability to work on multiple projects simultaneously. We expect you to have the ability to work independently and collaboratively. Certain level of resistance for stress will also be required. Last but not least, we expect you to have a solid understanding of the global legislative framework for pharmacovigilance and know what it takes to remain compliant with them.

As a PV Specialist, you will report directly to the Director of PV Services.

General areas of responsibilities:

– ICSR data entry, follow-up, quality control and submission in Tepsivo Safety Database
– Support with Tepsivo Safety Database and Tepsivo Platform development
– Global and local literature monitoring in Tepsivo Literature
– Support in audits and inspections
– Tracking all activities in Tepsivo Platform, Tepsivo Safety Database, Tepsivo Literature, Tepsivo News and others as applicable
– Promote company’s philosophy and mission to modernize the world of Pharma

Our modus operandi
We’re a modern company and believe in a decentralized approach to management. This means we are strong supporters of providing enough freedom on where you work as well as how. Your boss will not look over your shoulder every day. Instead, you will have transparent access to key company data and objectives, and we will expect you to make informed decisions on the areas of your responsibility. In return, we expect you to be fully accountable for your own work, good or bad.

This can only work with people of the right talent and those who genuinely share our values and philosophy. Tepsivo solutions have removed, automated, or otherwise digitized routine PV activities and what is left is value-added work requiring a strong skill set. If you’re selected to work at Tepsivo, that means you’re already among the best of your peers, and that is something we hope to foster and reward accordingly.

If you’re ready for a true challenge, then let’s talk.

Application – Pharmacovigilance Specialist

Submit your CV and don’t forget to add your cover letter so we understand what motivates you about this opportunity.