People. Passion. Possibilities. Three words that make a world of difference.
More than a job. Its a chance to make a real difference.
Welcome to AbbVie! As part of an international company with 50000 employees worldwide and around 3000 employees in Germany you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care Do you want to contribute to improving patients quality of life through your expertise In a challenging work environment that offers opportunities of developing and increasing your own skills Youve come to the right place!
As part of the Regional Safety Operations team at the Wiesbaden site you will be working with talented people and experienced management experts to maintain a highfunctioning PV system enhance our drug safety processes and protect patient wellbeing.
Together we break through as (Associate) Pharmacovigilance Manager
As an (Associate) Pharmacovigilance Manager you will support the Pharmacovigilance Lead (PV Lead) and the Affiliate Safety Representative (ASR) in all aspects of role and responsibilities ensuring that the local PV activities and requirements are in line with AbbVie Processes and procedures the Code of Business Conduct and the local laws.
Make your mark :
Your main responsibilities will be as follows :
Support ASR in setting a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate
Collaborate with Pharmacovigilance and Patient Safety Epidemiology R&D Quality Assurance (PSEQ) regional teams and local PV teams to support the PV Lead and the ASR in ensuring oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations internal company timelines / standards.
Support the ASR and PSEQ Regional PV Teams in ensuring overall training compliance with corporate procedures and local PV requirements coordinating the maintenance of the local PV Training matrix and the development and subsequent rollout of additional PV Training as required (e.g. Risk Minimization Trainings)
Ensure that PV requirements are implemented in all applicable observational studies / PostMarketing Observational Studies (PMOS) and InvestigatorInitiated Studies (IIS).
Support ASR and PSEQ Regional teams to ensure quality systems are in place and in line with corporate procedures and local requirements :
Support ASR and PSEQ Regional Teams in managing internal PV audits of affiliate service providers / third parties and Regulatory Authority PV Inspections (including corresponding CAPA development and actiontracking to completion in a timely manner)
Coordination of the local PV Mailbox
Qualifications : SKILLS
EDUCATION / KNOWLEDGE
EXPERIENCE
What we offer you :
Zustzliche Informationen :
AbbVie setzt sich fr Chancengleichheit ein und verpflichtet sich mit Integritt zu arbeiten Innovationen voranzutreiben Leben zu verndern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber / Veteranen / Behinderten.
Remote Work : Employment Type :
Fulltime
Key Skills
Restaurant Experience,Fashion Retail,Customer Service,Hospitality Experience,Store Management Experience,Assistant Manager Experience,Management Experience,Retail Sales,Leadership Experience,Supervising Experience,Restaurant Management,Retail Management
Experience : years
Vacancy : 1
Manager All Gender • Wiesbaden, Hesse, Germany