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Specialist Global PV Operations I

STADA Group · GB

Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia an...

Job description

Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.: Specialist Global PV Operations I Place of work : Belgrade Type of contract : Fix term - Maternity cover About the job: As Specialist Global PV Operations I in the area of signal and risk management for pharma-covigilance (PV), you will work in a global function, take over the detection and assessment of safety signals from various sources and perform risk management related activities in the Global PV System of the STADA Group. Responsibilities: - Signal detection, validation and medical/pharmacological assessment of signals related to STADA medicinal products - Scientific literature search for safety signals and assessment - Review of PV-related publications (e.g. CMDh, PRAC, CHMP Meeting Minutes, CMDh Press Release) Monitoring of EMA/EC websites for PSUSA and referral outcomes and timely initiation of label changes via...