Thermo fisher Scientific is hiring Safety Specialist-III – Apply Now

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Welcome to a career opportunity that blends your passion for safety with cutting-edge scientific innovation! Thermo Fisher Scientific, a global leader in serving science, is currently seeking a talented Safety Specialist-III to join our dynamic team.

Thermo Fisher Scientific

If you’re driven by a commitment to creating and maintaining a safe working environment while contributing to groundbreaking scientific advancements, this could be the perfect fit for you. Discover how you can play a crucial role in both ensuring the well-being of our team members and supporting groundbreaking research. Join Thermo Fisher Scientific on a journey where safety meets scientific excellence!

Position: Safety Specialist-III

About the job
Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed 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.

1. Works independently to perform day-to-day PV activities. May participate in on call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
2. Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff.
3. 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.
4. Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
5. 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.

Additional / Specific Job Responsibilities:
1. Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information, and analysis of similar events (AOSE) for both developmental and market-authorized products.
2. Serves as the primary point of contact for low, medium and high complexity literature projects (e.g. high complexity projects with more than 5 products, projects involving review for ICSRs, signal-relevant, aggregate safety report-relevant safety information and/or AOSE, and projects with high volume of citations).
3. Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
4. Participates in departmental initiatives.
5. May prepare for and attend audits, inspections and bid defenses.

Job Complexity: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Job Knowledge: A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, dedicated, journey-level position.

Supervision Received: Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Business Relationships: Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

Education and Experience:
1. Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
2. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
3. 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:
1. Comprehensive knowledge and experience of global pharmacovigilance requirements relating to literature surveillance
2. Thorough understanding of pathophysiology and the disease process
3. Strong knowledge of relevant therapeutic areas as required for processing AEs
4. Excellent critical thinking and problem solving skills with ability to evaluate and raise appropriately
5. Proficient at complex clinical study administration including budget activities and forecasting
6. Excellent oral and written communication skills including paraphrasing skills
7. Good command of English and ability to translate information into local language where required
8. Computer literate with the ability to work within multiple databases
9. Proficient in Microsoft Office products (including Outlook, Word, and Excel)
10. Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations
11. Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
12. Strong attention to detail
13. Ability to maintain a positive and professional demeanor in challenging circumstances
14. Ability to work effectively within a team to attain a shared goal

Management Role:
Lead: Provide guidance / mentoring to a small unit or group performing the same or similar tasks where the majority of the time is spent performing the same or directly related individual tasks. Responsible for assigning, reviewing or checking work. May be required to complete tasks of unit members when the need arises. No authority for personnel actions (e.g. salary reviews, promotions, performance reviews, disciplinary actions).

Working Conditions and Environment:
1. Work is performed in an office environment with exposure to electrical office equipment
2. Daily exposure to high pressure and intense concentration
3. Daily interactions with clients/associates
4. Long, varied hours on occasion
5. Travel required on occasion domestic and/or international

Physical Requirements:
1. Frequently stationary for 6-8 hours per day
2. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
3. Frequent mobility required
4. Occasional crouching, stooping, bending and twisting of upper body and neck
5. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
6. Ability to access and use a variety of computer software developed both in-house and off-the-shelf
7. 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
8. Frequently interacts with others to obtain or relate information to diverse groups
9. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals
10. Requires multiple periods of intense concentration
11. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
12. Ability to perform under stress and multi-task
13. Regular and consistent attendance

Percent Billable: 80%-100%

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