Senior Pharmacovigilance Specialist

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

As a Senior Pharmacovigilance Specialist, you will play a vital role in supporting the management and maintenance of the Pharmacovigilance function in the Czech Republic. Your responsibilities will include ensuring regulatory compliance in collaboration with Teva Global and European PV teams, as well as local Teva management. This is an exciting opportunity to contribute to the safety and quality of our products while developing your expertise in pharmacovigilance within an international environment.

How you’ll spend your day

• Participate on establishing and maintaining a compliant Pharmacovigilance function in the Czech Republic.
• Act as a back-up of the local representative for Pharmacovigilance oh behalf of Teva for local Regulatory Authorities SÚKL (State Institute for Drug Control) and UVZSR (Public Health Authority ofthe Slovak republic).
• Act as a back-up of the local Teva representative for pharmacovigilance in case of PV inspections conducted in the Czech Republic.
• Participate in ensuring that all Local and Global tracking systems are updated on a regular basis.
• Participate in appropriate recording and documentation of all processes and procedures that are subject to audit.
• Participate in maintenance of the Local Business Contingency Pian for pharmacovigilance activities, as necessary.
• Participate in the Global and European PV meetings.
• Back-up of Slovak Pharmacovigilance Officer -provides full back up in case of her absence or holiday.
• Participate in ensuring appropriate management and processing of all individua! case reports and periodic reports received, to ensure regulatory reporting compliance. This shall include close interactions with all local functions with the potential to receive individua! safety reports, including, but not limited to Quality Complaints, Medical Affairs/lnformation, Sales Representatives.
• Participate in the review, maintenance and documentation for individua! case reports generated from all local organised safety data collection systems and market research surveys.
• Participate in the case reconciliation with all interna! and external partners, as appropriate.
• Participate in the revision of local labelling as identified following CCSI review, in a timely manner, liaising with Regulatory Affairs and Medical if appropriate, and according to local procedures.
• Participate in the preparation and implementation of any local Risk Management Pian and all risk minimisation measures as required, in collaboration with Medical Affairs, Regulatory Affairs, Marketing, external partners, and with Global and European Pharmacovigilance as needed. Ensure liaison with the SIDC, as required locally.

Your experience and qualifications

• Master's degree in natural sciences, pharmaceutical sciences, or equivalent
• A minimum of 2-year experience in pharmacovigilance
• Strong communication skills in both verbal and written English and Czech
• Integrity and a demonstrable sense of responsibility
• Strong focus on internal/external customers
• Prioritization
• lndependent thinker, but a team player
• Able to work in a changing and flexible environment

Enjoy a more rewarding choice

• Dynamic and professional atmosphere
• Hybrid model 3 days in office, 2 days HO per week
• Motivating annual bonus
• 5 weeks of paid holiday and 3 sick days per year
• Mobile phone, laptop
• Cafeteria benefit systes, MultiSport card

Make a difference with Teva Pharmaceuticals

Please submit your CV in English language.

Please note that only shortlisted candidates will be contacted.

Reports To

Pharmacovigilance Manager / Local Safety Officer

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