Qualified Person - PV, EU

ThermoFisher Scientific; Roma; Ibrido; EUR 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific seeks an EU/UK QPPV to lead pharmacovigilance activities for selected clients. You will ensure compliance with EU directives, oversee safety services and interact with national stakeholders.

You will promote best practices, manage budgets, and coordinate with teams to deliver high-quality PV outcomes across trials and products.

Competenze

• Master’s degree in Pharmacy, Medicine or equivalent.
• Previous experience as EU/UK QPPV.
• Extensive EU PV experience (at least 5 years).
• PV Regulatory Inspection experience.
• Expert knowledge of pharmacovigilance regulations.
• Working knowledge of pharmacovigilance databases.

Mansioni

• Fulfills EU QPPV/Deputy EU QPPV role for selected clients per EU Directive 2001/83/EC and CRG procedures.
• Contributes to scientific safety services, including safety writing and signal detection.
• Oversees and supports national level contact persons as applicable.
• Promotes best practices and engages in process improvements and trainings.
• Delivers input into client proposals and presents at business development meetings for QPPV services.
• Manages scope of work, budget oversight and resourcing for QPPV services clients.
• Works on complex issues requiring in-depth evaluation of factors.

Conoscenze

Pharmacovigilance

Regulatory knowledge

Communication

Stakeholder management

Attention to detail

Problem solving

Data analysis

Interpersonal skills

Budgeting/Forecasting

Team leadership

Formazione

Master’s degree in Pharmacy/Medicine or equivalent

Strumenti

Pharmacovigilance databases

Descrizione del lavoro

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

A Day in the Life

Fulfills the role of European Union (EU) and/or UK Qualified Person for Pharmacovigilance, or Deputy EU/UK QPPV, for selected clients. Works with management to promote services to potential clients and develops service offerings for both developmental and market authorized compounds.

Essential Functions

• Fulfills EU QPPV/Deputy EU QPPV role for selected clients in accordance with EU Directive 2001/83/EC, associated EU regulatory guidance and applicable CRG procedures.
• Contributes to scientific safety services, such as safety writing, signal detection and/or literature surveillance.
• Oversees and supports the activities of contact persons at a national level, when applicable.
• Promotes good practices within the department, including through engagement in process improvement activities and delivery of training.
• Provides input into development of client proposals, and presents at business development meetings to promote QPPV services to potential clients.
• Manages scope of work, budget oversight and resourcing for both new and existing QPPV services clients
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

Keys to Success

Education and Experience

Master’s degree in Pharmacy, Medicine or equivalent

Previous experience as EU/UK QPPV

Extensive experience in pharmacovigilance (inclusive of at least 5 years of EU-specific PV experience)

PV Regulatory Inspection experience

Knowledge, Skills and Abilities

• Proven ability to establish processes and build expertise in drug safety
• Ability to manage internal and external stakeholders and to exercise creativity and judgement
• Excellent oral and written communication
• Excellent interpersonal skills
• Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve
• Expert knowledge of the regulations governing pharmacovigilance
• Working knowledge of pharmacovigilance databases
• Good overall knowledge of the drug development process
• Understanding of medical/coding dictionaries and ontologies and data interoperability
• Expertise in budgeting, forecasting and fiscal management
• Ability to present safety services to potential clients

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.