At Thermo Fisher Scientific, you\xe2\x80\x99ll 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 \xe2\x80\x93 now and in the future. Our 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. As 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. This is a remote role based in India.
Summarized Purpose Responsible for the overall planning, coordination, and delivery of pharmacovigilance services for large, complex projects. Oversees and may perform day-to-day Pharmacovigilance (PV) activities 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. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. May directly oversee staff and provide input on individual performance.
Key responsibilities:

• Works independently to oversee day-to-day PV activities. May participate in on[1]call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Functions in a lead role. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
• Reviews 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.
• Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
• Responsible 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.

Keys to Success

• 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. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
• Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.

Education and Experience:

• Bachelor\'s degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ 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 and Abilities

• Excellent understanding of pathophysiology and the disease process
• Expertise in relevant therapeutic areas as required for processing AEs
• 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
• Ability to motivate, mentor and provide guidance to less experience staff
• Proficient at complex clinical study administration including budget activities and forecasting
• Excellent oral and written communication skills including paraphrasing skills
• Good command of English and ability to translate information into local language where required
• Advanced computer skills with the ability to work within multiple databases
• Advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
• Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations
• Strong attention to detail
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team to attain a shared goal

-Ability to mentor and assist managers with designated tasks (Financial, KPI\xe2\x80\x99s- Quality & Productivity etc). Physical Conditions/Work Enviornment Thermo 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: Working conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Daily exposure to high pressure and intense concentration
• Daily interactions with clients/associates
• Long, varied hours on occasion
• Travel required on occasion domestic and/or international.

Physical Requirements:

• 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 and 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! 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! 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.
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