Qualified Person - PV, EU

ThermoFisher Scientific; Porto; Híbrido; EUR 120 000 - 180 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is seeking an experienced professional to fulfill the EU QPPV/Deputy EU QPPV role for selected clients, ensuring compliance with EU pharmacovigilance directives and CRG procedures.

The role involves contributing to safety services, coordinating national contact points, and promoting best practices. You will manage budgets and resources for QPPV services and engage in business development activities with clients.

Qualificações

• Master’s degree in Pharmacy, Medicine or equivalent.
• Previous experience as EU/UK QPPV.
• Extensive experience in pharmacovigilance (EU-specific PV experience, 5+ years).
• PV Regulatory Inspection experience.

Responsabilidades

• Fulfills EU QPPV/Deputy EU QPPV role for selected clients in accordance with EU Directive 2001/83/EC, related guidance and CRG procedures.
• Contributes to scientific safety services (safety writing, signal detection, literature surveillance).
• Oversees and supports activities of contact persons at a national level, when applicable.
• Promotes best practices within the department and delivers training.
• Prepares client proposals and presents at business development meetings to promote QPPV services.
• Manages scope, budget oversight and resourcing for QPPV services clients.
• Works on complex issues requiring in-depth evaluation of variable factors.
• Determines methods and procedures for new assignments and coordinates team activities.

Descrição da oferta de emprego

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.