Specialist Global PV Operations I

As Specialist Global PV Operations, in the area of signal and risk management for pharmacovigilance (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.

• 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 the safety variation process
• Management and preparation of Risk Management Plans (RMPs)
• Performance of routine Pharmacovigilance Activities resulting from RMPs (e.g. Targeted Questionnaires)
• Preparation of Medical Risk Assessments and Clinical Overviews for safety variations
• Support business development regarding the evaluation of new projects
• Medical and pharmacological evaluation of Individual Case Safety Reports (ICSRs) from spontaneous and solicited sources, scientific literature and Competent Authorities
• Reference: YfUg-Fn7faTTmTNE-VNoVeqL-Tee66_nsIezmhbe2xRtxbmfHU4BitAT5hsurJmU

• University degree in pharmacy, human medicine or natural sciences
• Good communication skills
• Fluent in English (orally and in writing)
• Responsible, careful and independent work
• Structured, result-oriented work style
• Very good software skills (MS-Office, databases)

• Private healthcare insurance (with the option of privileged use for family members)
• Ongoing professional development through specialized education and training
• A platform for learning 14 foreign languages, using various learning styles, including conversation courses
• Personalized mental health and wellbeing support for employees and their families through the Kyan Health app