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 general 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.
Discover Impactful Work:
Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region. Works with senior management and develops consistent internal processes and ensures compliance with established processes. Assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with company` standards. Supporting regional leads in day‑to‑day operations.
A day in the Life:
- Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the harmonization of processes across the regions.
- Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the management of innovation projects for increasing Regional Team efficiency.
- Support the Regional PV Leads in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
- Support the Regional PV Leads in the revision of documents pertinent to Regional PV tasks
- Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region.
- Contribute to the Pharmacovigilance System Master File (PSMF) data collection in any applicable country/region
- Contribute to increase the visibility of the GPS team/function throughout the company.
- Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed.
- Develop relationships with cross functional teams as it relates to adverse event reporting and other pharmacovigilance activities.
- Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements.
- Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team.
- Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
- Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance as it relates to the assigned tasks.
- Drive Continuous Improvement initiatives as needed.
Education:
- Master's degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
- At least 7-12 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety
Knowledge, Skills, Abilities:
- Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
- Knowledge of the drug development process, GXP quality and compliance requirements
- Earlier experience in managing PSMF is a plus
- Good presentation skills with the ability to communicate complex issues clearly
- Good planning and organizational skills with ability to manage competing priorities
- Good oral and written communication skills
- Ability to motivate, influence, and collaborate with multidisciplinary teams
- Ability to work independently and in a global environment
- Understanding of safety business processes and systems for the collections of adverse events
- Problem solving, conflict resolution and critical thinking skills
- Relevant computer skills, including proficiency with Microsoft Office Suite
- Fluency in written and spoken English
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.
Apply today
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.