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.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

We hire the best, develop ourselves and each other, and recognise 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:

Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to high in complexity or which concern low to high complexity products. Additionally supports mentoring of more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.

Essential Functions:

Serves as a creator/contributor for signal detection and assigned product safety scientist tasks.

• Supports local product label updates (e.g., Summary of Product Characteristic (SmPC)) and Company Core Data Sheet (CCDS) updates.

• Authors responses to authority queries/actions related to authorities' announcements.

• Serves as a contributor for aggregate reports and benefit-risk assessment, supports Periodic Safety Update Report (PSUR) single assessment (PSUSA) responses.

• Authors justification documents/ reviews cumulative safety data upon request to support safety variations, new applications, and renewals.

• Supports scientific literature surveillance.

• Maintains safety surveillance tracker/system.

• Supports Annual Company Core Safety Information (CCSI) reviews.

• Maintains safety surveillance tracker/system.

• Supports implementation of MedDRA version upgrades-reviews updates/term changes, updates coding guidelines and strategies, supports re-coding of events in the Safety Database System as needed.

• Consults clients on safety-related issues.

• Leads small FSP projects.

• Supports training and mentoring of junior colleagues.

• Contributes to development of processes, tools and systems.

• Participates in bid defense and proposal development activities.

• Works within multiple company and client systems. Interacts with project team members and clients.

• Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.

• Participates in departmental initiatives; Serves as a subject matter expert in designated area.

• Signal detection and risk management of investigational medicinal products (IMP).

• Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.

Keys to Success:

Education and Experience:

Bachelor's degree

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Knowledge, Skills and Abilities:

• Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets

• Excellent attention to detail, data interpretation and medical-scientific writing skills

• Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately Solid project management skills with the ability to manage multiple projects simultaneously and ability to redress issues proactively with limited management intervention

• Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise

• Proficient at complex project administration including budget activities and forecasting

• Excellent oral and written English language communication skills, including paraphrasing skills

• Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)

• Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience

• Ability to work effectively within a team to attain a shared goal

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! http://jobs.thermofisher.com

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.