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GPV Operations Specialist/Manager Air, Parma
Client: Chiesi Group
Location: Parma, Italy
Job Category: Other
EU work permit required: Yes
Job Reference: a57a6b4a7932
Job Views: 2
Posted: 24.04.2025
Expiry Date: 08.06.2025
Job Description
Who we are looking for
Main Responsibilities
* Collaborate with the Global PV Operations Unit Head, Specialists, and Managers on projects within the assigned Business Area.
* Provide input within the GPV specific Business Unit.
* Manage clinical trials, data collection, and Compassionate use/expanded access programs, including non-interventional studies like PASSs, and revise/draft/archive relevant documents.
* Oversee/review adverse event reports for investigational and marketed drugs, ensuring regulatory compliance and documentation completeness.
* Monitor PV activities of CROs involved in studies.
* Perform Quality Control activities.
* Contribute to global SOPs, WIs, and other controlled documents.
* Support other PV activities globally and at the affiliate level.
* Lead cross-functional projects and processes.
* Participate in audits and inspections.
* Ensure compliance with regulations, policies, and procedures.
* Participate in departmental meetings and project teams.
* Represent the GPV department in cross-functional teams and projects.
Experience Required
At least 3 years of Pharmacovigilance experience in the Pharmaceutical or Biotechnology industry, including a minimum of 1 year in Post-Market safety.
Education
Master's degree in science, medicine, biology, pharmacy, or related fields. Additional Pharmacovigilance background is a plus.
Languages
Technical Skills
* Knowledge of national and international safety reporting regulations (post-marketing and clinical trials).
* Knowledge of MedDRA coding principles.
* Project and performance management skills.
* Proficiency in Office suite, safety databases, and data management systems.
Soft Skills
* Quality orientation
* Goal orientation
* Problem solving
* Stress management
What we offer
Join a dynamic, fast-growing, challenging, and friendly environment. At Chiesi, we believe our people are our most valuable asset, investing in continuous training, learning, and development. We promote a healthy work environment and collective well-being, offering flexible working arrangements, remote work, relocation support, tax assistance for foreign colleagues, and other people-care services.
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