Teva Senior Pharmacovigilance Specialist 

Czechia, Prague, Prague 

867849429

As a

• 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.

• 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

• 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

Pharmacovigilance Manager / Local Safety Officer

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