Global Pharmacovigilance Operations Lead in Garching bei München bei ITM Isotope Technologies Munich SE

Your Role:

• Serves as primary day-to-day resource and contact for other functions within ITM for Pharmacovigilance operational activities
• Ensure compliance with global AE/SAE reporting requirements for all post-marketed products and products in development programs
• Ensure appropriate procedures are in place for centralized database operations, create robust case processing workflow and coding conventions, oversee validation status of the safety database
• Provide and communicate regularly with Pharmacovigilance provider and develop quality ICSR case processing reporting metrics (includes monitoring of key performance indicators and quality metrics of PV staff regarding outsourced PV activities)
• Set-up and keep up to date PV procedures to ensure inspection readiness from a PV Operations perspective
• Organize and record management of PV documentation and procedural documents (eg. Safety Management Plans, PV Agreements) to ensure inspection readiness
• Assist in management of company and Pharmacovigilance inspections
• Support and/or provide internal and external training on ICSR activities, safety procedures and processes including clinical and post-marketing regulatory reporting requirements
• Support and/or provide assistance in product filing activities
• Fulfilling the role of the German Deputy Graduated Plan Officer (Stufenplanbeauftragte) according to §63a of the German Drug Act (Arzneimittelgesetz, AMG) and §19 of the German Drug and Drug Substance Act (Arzneimittel und Wirkstoffherstellungsverordnung, AMWHV) as well as in accordance with ITM DOK-01601
• Support Pharmacovigilance leadership in assigned activities and actively participate in daily Pharmacovigilance activities with a” can-do, hands-on, positive attitude”

What we are looking for:

• Relevant life science or healthcare qualification and/or 7+ years of relevant global Pharmacovigilance experience/expertise, with experience in operational and compliance position
• Demonstrated knowledge of relevant FDA, EMA, and ICH guidelines, initiatives, and regulations governing both clinical trial and post-marketing safety environments
• Experience in case processing, database migrations, case workflow creation and coding convention is a must
• Ability to navigate fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must
• Knowledge of MedDRA dictionary with relevance to adverse event coding
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (Clinical Operations, Clinical Science, Data Management, Medical Affairs) and external vendors

What we offer:

• A modern workplace and exciting opportunities in an evolving and fast growing company
• Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
• A collegial corporate culture and short communication channels
• Flexible working hours with an attractive salary package and diverse corporate benefits