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Drug Safety Expert
2 weeks ago
Be a part of the winning culture
At Zentiva, we are a team of 4.700 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.
Drug Safety Expert
We're currently looking for a new colleague to join our Pharmacovigilance team. Each team member is individually responsible for several molecules, managing activities such as reporting, documentation, and safety studies. At the same time, collaboration is a key part of our work — we regularly consult, share insights, and cooperate not only within our team, but also with colleagues from Quality, Regulatory Affairs, and Clinical teams.
It's a role that offers both independent ownership and cross-functional teamwork — ideal for someone who enjoys both structure and collaboration in a meaningful field.
Your responsibilities
- Drug safety evaluation during post-authorization period; analysis of internal (case reports) and external (scientific literature) data.
- Elaboration of safety related parts (benefit-risk, epidemiology) for pharmacovigilance documents (Periodic Benefit Risk Evaluation Report, Addendum to the Clinical Overview, Risk Management Plan).
- Participation in signal management process; evaluation of the association between drug exposure and adverse event occurrence.
- Participation in case management process .
- Medical review of ICSRs.
- Participation in routine Pharmacovigilance activities.
- Effective communication with relevant stakeholders.
We require
- University degree MD (preferably) or PharmD.
- Proven excellent communication and organization skills.
- Interest in the area of pharmacovigilance.
- Willingness and desire to learn new things.
- Advanced level of English,
- Confident user of MS Office, tech savvy individual.
- Detail oriented, able to work under pressure and both individually and in the team.
- Previous experience in pharmacovigilance or clinical practice will be an advantage.
What is in it for you
- An opportunity to work for a successful international pharmaceutical company.
- An opportunity to learn newest approaches in managing creative and highly adaptive business organizations.
- Pleasant and dynamic working environment.
- Continuous personal development.
- An attractive compensation & benefits package.
- Above standard social and benefit program.
