Safety Scientist II (Client-Dedicated) - 6 months contract with possible extension

Thermo Fisher Scientific

18d ago

Job
Full-time
Senior Level
Research & Development
Healthcare
Milan

AI generated summary

You need a relevant degree, 5+ years in pharmacovigilance, signal detection experience, Oracle Empirica and MedDRA knowledge, strong communication, and project management skills.
You will manage safety signal detection, evaluate data, prepare reports, mentor colleagues, advise clients, and ensure compliance with regulations while coordinating project activities.

Requirements

Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences fields.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Pharmacovigilance/safety risk management experience.
Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets.
Extensive signal detection & management experience is a must.
Working knowledge of Oracle Empirica.
Understanding of the principles of databases, querying data sources as well as developing and applying search strategies.
Working knowledge of MedDRA.
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.
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 Office products (including Outlook, Word, and Excel).
Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience.
Ability to work effectively within a team to attain a shared goal.

Responsibilities

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 activities including generation, review, and presentation of aggregate safety data, mentoring of more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.
Serves as a creator/contributor for signal detection and product safety scientist tasks.
Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.
Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)
Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.
Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.
Prepare data for and actively participate in safety governance processes.
As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator’s Brochure (IB), or Informed Consent Form (ICF)
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.
Supports training and mentoring of junior colleagues.
Contributes to development of processes, tools and systems.
Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.
Participates in departmental initiatives; Serves as a subject matter expert in designated area.
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.
Frequent contacts with internal personnel and outside customer representatives.

FAQs

What is the duration of the contract for the Safety Scientist II position?

The contract is for 6 months with a possible extension.

What are the educational requirements for this position?

A Bachelor’s or Master’s degree in pharmacy, nursing, healthcare, or other life sciences fields is required.

What level of experience is expected for applicants?

Applicants should have comparable experience of at least 5 years in a relevant field.

Is prior experience in pharmacovigilance required?

Yes, pharmacovigilance/safety risk management experience is necessary.

What are the primary responsibilities of the Safety Scientist II?

Responsibilities include signal detection, product safety activities, preparation of safety reports, mentoring junior colleagues, and advising clients on safety-related issues.

Are there opportunities for career advancement in this role?

Yes, the company offers continued career advancement opportunities through award-winning training and development programs.

What software knowledge is essential for this position?

Working knowledge of Oracle Empirica and MedDRA is required, along with advanced skills in Microsoft Office products.

How would you describe the work environment for this role?

The role is office-based with considerations for team collaboration and client interaction.

Is there a focus on teamwork in this position?

Yes, teamwork is emphasized, and the ability to work effectively within a team to attain shared goals is crucial.

What skills are necessary for effective communication in this role?

Excellent oral and written English language communication skills are essential, including the ability to paraphrase effectively.

Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.