[Hiring] Qualified Person - PV @Thermo Fisher Scientific

Role 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.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

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.

Qualifications

• 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.

Benefits

• Continued career advancement opportunities.
• Award-winning training.
• Benefits focused on the health and wellbeing of our employees.