Local Person for Pharmacovigilance (LPPV)- CZ

at  Pharmalex

ARE YOU LOOKING FOR A DYNAMIC COMPANY WITH DAILY NEW CHALLENGES AND OPPORTUNITIES?

Then, Pharmalex is your next career move! Pharmalex, now part of Cencora, is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
We are looking for a Local Person for Pharmacovigilance (LPPV) in Czech Republic, who will be responsible for the establishment and maintenance of the marketing authorisation holder’s local pharmacovigilance system, and the performance of local Pharmacovigilance Operations.

YOUR JOB

• Act as primary contact for PV for Competent Authority in the Territory, including 24/7 availability if legally required.
• Interface between the EU-QPPV / Global PV team at client and the local regulatory authority
• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety
• Integrated first Level Medical Information and PQC Support
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties

Your Profile

• University degree in Medicine, Pharmacy or Life Science
• Several years’ experience and profound knowledge in the field of pharmacovigilance
• Expertise, experience and knowledge regarding relevant global and local legislative and non-legislative guidelines on pharmacovigilance
• Detailed knowledge of related SOPs (global and local)
• Participation in all relevant courses of instruction such as internal trainings and applicable external courses
• Experience in all operative tasks that are performed by the members of the pharmacovigilance department
• Familiarity with industry principles of pharmacovigilance
• Ability to organise operational procedures and mange different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects)
• Ability to adjust rapidly to new, unknown, challenging situations
• Ability to analyse and solve problems and to develop possible solutions
• Autonomous, concentrated and high-quality work
• Ability to work in a team
• Sense of responsibility
• Either Slovak or Czech are a must. Very good command of English

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us.
Agencies only by prior agreement for the specific job opportunity

Please refer the Job description for details