Specialist Global PV Operations II

As Specialist Global PV Operations II in the area of Periodic Safety Update Reports (PSURs) and EU referrals for pharmacovigilance (PV), you will work in a global function, take over the preparation of PSURs and perform safety assessments in the Global PV System of the STADA Group.

• Planning, preparation and medical writing of Periodic Safety Update Reports (PSURs) and Addendum to Clinical Overview (AdCO) for renewals of Marketing Authorisations of STADA Group companies worldwide
• Literature search and scientific evaluation of literature articles for PSURs and AdCOs
• Monitoring of updates for PSUR planning according to regulatory requirements
• Tracking of PSUR assessment reports and internal communication of assessment outcome
• Writing response documents to requests from Competent Authorities for PSUR assessment reports and referral procedures
• Administrative support for the maintenance of Reference Safety Information
• Support of Local Pharmacovigilance Units of STADA affiliates worldwide in terms of PSUR and AdCO management and implementation of standard operating procedures (SOPs)
• Writing and updating of working instructions (SOPs and OPs)
• Reference: poYo7AKgKE-lvrrbqAW22P1oBpDlj6kV7Rkk8OjilElaX58-fzVPdgGkzAjDE8aN

• University degree in pharmacy, health sciences, medicine or a related discipline
• Professional experience in the pharmaceutical industry in area of pharmacovigilance desired
• Good communication skills
• Fluent in English (orally and in writing)
• Responsible, careful and independent work
• Structured, analytic and 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