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Job Information

ThermoFisher Scientific Drug Safety Reporting Senior in Remote, India

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.

Discover Impactful Work:

Responsible for overall planning, co-ordination and delivery of safety reporting for large and complex projects. Leads complex projects and programs, including full project oversight and maintenance of metrics, compliance, and finances. Recommends updates to procedures, regulatory intelligence activities and other initiatives related to safety reporting. Provides training and support to other team members and serves as primary point of contact in the absence of the manager.

A day in the Life:

  • Receives, prepares and submits safety reports to applicable parties, ensuring compliances at all stages.

  • Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress. Exercises independent judgment to troubleshoot, resolves project issues and identifies areas for improvement.

  • Leads and monitors large and complex projects effectively to ensure that all aspects of the project are completed successfully and on time.

  • Attends and presents at various meetings as required.

  • Facilitates and advises on company, client and regulatory audits where required.

  • Provides training and support to lower-level team members, mentors new starters, provides input on individual performance and shares ideas and suggestions with team members.

  • Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.

Keys to Success:

Education

  • Bachelor's degree

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, and experience.

Knowledge, Skills, Abilities

  • Advanced knowledge of medical terminology

  • Excellent Microsoft Office skills and understanding of database functionality

  • Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements

  • Excellent critical thinking and problem solving abilities

  • Demonstrated ability to lead, mentor and motivate others

  • Ability to work well in a collaborative team environment

  • Strong attention to detail with ability to work with ambiguity and complexity

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

  • Demonstrated initiative and applies persuasion and negotiation skills to complete assigned tasks, delegating effectively where required

  • Ability to apply advanced knowledge, skills, and expertize to communicate and assist internal clients

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.

Accessibility/Disability Access

Job 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.

*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.

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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