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GPV Operations Specialist, Air - Cary, United States - Chiesi USA
Description
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi."
Purpose
Support the Pharmacovigilance program with the collection and review of safety data from clinical trials and the set-up of related documents in compliance with current regulations.
Main Responsibilities
Maintain and manage the relation with other Sponsors:
o oversight and support for all clinical trial pharmacovigilance activities
o exchange and migration of safety data
o support in the preparation of regulatory documents
o Preparation of Agreements to define the responsibilities of each party
* Manage the pharmacovigilance activities of Chiesi-Sponsored clinical trials:
o Study set-up (review/approval of PV-relevant clinical trial documents)
o SAEs/SUSARs processing/submission and reconciliation
o Oversight and interaction with monitoring CRO
o Compliance monitoring
o Training to investigators
* Participate in audit and inspection activities
Experience Required
Pharmacovigilance experience: 2+ years
* Experience in pharmaceutical industry preferred.
* Comprehensive understanding of US federal regulations and processes related to clinical trial safety reporting
* Experience with Argus safety database required, Medidata RAVE preferred
* Proficiency using Microsoft Office (Word, Excel, PowerPoint), MS Teams, Adobe
* Demonstrated proficiency in Written, Verbal, and Face-to-Face communication
* Detail oriented with ability to multitask in a high-volume environment
* Able to work effectively on multi-disciplinary teams in order to achieve desired outcomes
* Skillfully plans, prioritizes, and executes multiple responsibilities in a highly dynamic work environment
Education
BS/BA related to healthcare or life sciences from a 4-year accredited university required.
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
