Drug Safety Reporting Senior

Thermo Fisher Scientific
US - Maryland - Severna Park
May 18, 2024
Pharmaceutical

At Thermo Fisher Scientific, youll 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!

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-#-#
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Associated topics:
clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator

Read the full job description and apply online on the recuiter's web-site

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