Job DescriptionSummarized Purpose:Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region.Assess current processes to ensure adherence to US safety regulatory requirements and where needed enhance and/or develop new processes while assuring consistency with global standards.Essential Functions:
Increase the visibility of the team/function with focus on US and Canada
Ensure strategic pharmacovigilance support in the region to Regulatory Affairs, Medical Affairs, US Commercial function, and the broader organization as required to contribute to enhancing global patient safety awareness.
Participate in health authority interactions throughout the product life-cycle as needed. Closely collaborate with other functions including regulatory, medical, communications, quality, legal, as well as other teams within Development.
Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with requirements.
Develop relationships across the organization as it relates to adverse event reporting and other pharmacovigilance activities.
Maintain an in depth knowledge of FDA regulations, expectations and regulatory authority contacts; and perform activities related to the interpretation and review of existing and evolving FDA safety requirements.
Lead and actively participate in audit and inspection readiness, support, and management together cross functional teams.
Engage in due diligence activities as needed when potential business partnerships or collaborations may take place.
Contribute to departments issue management, recommend and implement action plans for mitigation
Identify opportunities to align PV standards globally.
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 in the region.
Transparently communicate and/or escalate issues to leadership as appropriate.
Drive Continuous Improvement initiatives as needed.
May perform other tasks as appropriate.
Qualifications:Education and Experience:
Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
8+ years of experience in the pharmaceutical/biotech industry with at least 5years in pharmacovigilance/drug safety (experience with adverse event monitoring and reporting with digital/social media, market research, and relevant commercial and marketing related projects and programs is a plus)
Knowledge of the drug development process, GXP quality and compliance requirements,
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:
Excellent presentation skills with the ability to communicate complex issues clearly
Excellent planning and organizational skills with ability to manage competing priorities
Excellent oral and written communication skills
Strong 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
Demonstrated ability to author or contribute to complex documents
Relevant computer skills, including proficiency with Microsoft Office Suite
Fluency in written and spoken English
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
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.