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 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. \nLocation/Division Specific Information\nOur detailed, goal-oriented Pharmacovigilance colleagues 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. \nAs part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. \nDiscover Impactful Work:\nAs a Senior Safety Sepcialist you will perform and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. You will effectively collaborate with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. \nA day in the Life:\n•\tWorks independently to perform day-to-day PV activities. May participate in on call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. \n•\tOperates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff. \n•\tReviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. \n•\tReviews cases entered for quality, consistency and accuracy, including review of peer reports. \n•\tResponsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations\nKeys to Success: \nEducation\n•\tBachelor's degree or equivalent and relevant formal academic / vocational qualification \nExperience\n•\tPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).\nKnowledge, Skills, Abilities\n•\tThorough understanding of pathophysiology and the disease process \n•\tStrong knowledge of relevant therapeutic areas as required for processing AEs\n•\tExcellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately \n•\tProficient at complex clinical study administration including budget activities and forecasting \n•\tExcellent oral and written communication skills including paraphrasing skills \n•\tGood command of English and ability to translate information into local language where required \n•\tComputer literate with the ability to work within multiple databases \n•\tProficient in Microsoft Office products (including Outlook, Word, and Excel) \n•\tThorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations \n•\tAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision\n•\tStrong attention to detail \n•\tAbility to maintain a positive and professional demeanor in challenging circumstances \n•\tAbility to work effectively within a team to attain a shared goal \nPhysical Requirements / Work Environment \nThermo Fisher Scientific 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:\n•\tAble to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.\n•\tAble to work upright and stationary for typical working hours.\n•\tAbility to use and learn standard office equipment and technology with proficiency.\n•\tAble to perform successfully under pressure while prioritizing and handling multiple projects or activities.\n•\tMay require travel. (Recruiter will provide more details.)\nBenefits\nWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!\n\nOur 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. \nApply today! http://jobs.thermofisher.com\nThermo 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.\nAccessibility/Disability Access\nJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.\n*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.