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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 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:
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 activities including generation, review, and presentation of aggregate safety data, 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 product safety scientist tasks.
- Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.
- Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
- Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)
- Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.
- Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.
- Prepare data for and actively participate in safety governance processes.
- As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator’s Brochure (IB), or Informed Consent Form (ICF)
- Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity, or which concern low to high complexity products.
- Advises clients on safety related issues.
- Supports training and mentoring of junior colleagues.
- Contributes to development of processes, tools and systems.
- 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.
- 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.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Frequent contacts with internal personnel and outside customer representatives.
Keys to Success:
Education and Experience:
- Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences fields.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Pharmacovigilance/safety risk management experience
Knowledge, Skills and Abilities:
- Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
- Extensive signal detection & management experience is a must.
- Working knowledge of Oracle Empirica.
- Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
- Working knowledge of MedDRA
- 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
- 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.
