Čeština (Česká republika)English (United Kingdom)

Career

Regulatory Affairs & Pharmacovigilance data Officer

Responsibilities:

RA: 
ensure appropriate archiving of documentation and correspondence
monitoring local/EU legislation for new information related to the regulation
maintain RA database up to date
preparing of periodic overviews, reconciliations lists

PhV:
maintain internal PhV SOP’s and PSMF up to date
timely report/communicate with local abroad partner if applicable
help with preparing PSUR schedules, ordering and submitting PSURs in a timely manner
monitoring local/EU legislation for new information related to the regulation and legislation
participate on PV audits
interacting with partner companies on specific information as needed
regular literature monitoring- (including MLM) – maintenance about list of articles
check of data in PhV database

Requirements:
University degree (medical, pharmaceutical or natural science)
one year experience in RA/PhV at minimum
Basic experience in the field of pharmacovigilance
Excellent knowledge of English (written and spoken form)
Knowledge of relevant legislation of the Czech Republic, EU countries
Advanced knowledge of PC (excel, word)
Flexibility and loyalty
Responsibility for assigned tasks
Independence
conscientiousness

We offer:
An opportunity to broaden your knowledge and expertise in your field
Continuous professional and personal development
Mobil phone, notebook
Additional benefits according to company standards
the possibility of part-time work


Place: 
Brno, CZ

If interested, send your response in writing including your curriculum vitae to the email address:
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