**Work Schedule** Third Shift (Nights) **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. **Location/Division Specific Information** Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. **Office Location:** Seven/NEO Building, Bonifacio Global City, Taguig City, Philippines **Work Shift Schedule:** Night Shift (US business hours. Follows PH holidays) **Work Setting:** Hybrid; 1 to 3 days a week on-site Discover Impactful Work: Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR), as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP, Signal detection reports and CSR) **A day in the Life:** + Maintains understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel. + Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs. + Provides medical consultation to team members and answer all project/study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. + Provides safety reporting training on assigned projects/studies, as requested. + Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted. + Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. + Assists in writing (interpretation of safety data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. + Manages signal detection activities, scientifically reviews periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities **Keys to Success:** **Education** MD or equivalent required. History of an active medical license highly preferred. **Experience** Candidates should have at least one of the following: + Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years); Or + Direct experience in medical review and assessment of safety information/Pharmacovigilance(comparable to 3 years). 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, Abilities** + Fluent in spoken and written English + General medical knowledge of diagnostic and therapeutic approaches across multiple specialties. + Therapeutic expertise across one or more medical speciality or sub-specialities preferred. + Strong decision-making, problem solving, organizational skills and analytical skills + Excellent oral and written communication skills + Excellent interpersonal skills + Working knowledge of guidelines (FDA, ICH, EMA and GCP) + Understanding of basic biostatistics, data management, and clinical operations procedures + Excellent organizational skills + Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information + Working knowledge of the drug development process and thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies + Working knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape. + Working knowledge of marketed products pharmacovigilance regulations + Working knowledge of Drug Safety Dictionaries (e.g. MedDRA) + Working knowledge of relevant safety databases (e.g. ARGUS, ARISg) + Ability to act as a mentor/trainer to entry level staff within the Pharmacovigilance Department + Flexibility to travel domestically and internationally + Proficiency in basic computer applications + Ability to serve as the group liaison with other PPD groups and clients **Physical Requirements / Work Environment** + Work is performed in an office environment with exposure to electrical office equipment. + Occasional drives to site locations with occasional travel both domestic and international. + Frequently stationary for 6-8 hours per day. + Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. + Frequent mobility required. + Occasional crouching, stooping, bending and twisting of upper body and neck. + Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. + Ability to access and use a variety of computer software developed both in-house and off-the-shelf. + Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. + Frequently interacts with others to obtain or relate information to diverse groups. + Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. + Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. + Regular and consistent attendance. **Benefits** We 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! 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.