Safety Scientist Ii

hace 4 semanas

Ciudad de México Thermo Fisher Scientific A tiempo completo

**Safety Scientist II - EMEA, Remote**:
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 detailed, goal-oriented team members 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 tasks.

**Discover Impactful Work**:
At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

**A Day in the Life**:
Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to high in complexity or which concern low to high complexity products. Additionally supports mentoring of more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.

**Essential Functions**:

- Serves as a creator/contributor for signal detection and product safety scientist tasks which are low to high in complexity or which concern low to high complexity products.
- Serves as a creator/contributor for signal detection and product safety scientist tasks which are ultra-high in complexity or which concern ultra-high complexity products, under supervision by a more experienced team member.
- Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity or which concern low to high complexity products.
- Advises clients on safety related issues under supervision by a more experienced team member.
- Leads small FSP projects.
- Supports training and mentoring of junior colleagues.
- Contributes to development of processes, tools and systems.
- Participates in bid defence and proposal development activities.
- Works within multiple company and client systems. Interacts with project team members and clients.
- Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
- Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.
- 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.
- 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.

**Keys to Success**:
**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).

**Knowledge, Skills and Abilities**:

- Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
- Excellent attention to detail, data interpretation and medical-scientific writing skills
- 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 and ability to redress issues proactively with limited management intervention
- Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise
- Proficient at complex project administration including budget activities and forecasting
- Excellent oral and written English language communication skills, including paraphrasing skills
- Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Of

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