Senior Safety Scientist

Alira Health Group; Verona; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global health advisory firm is seeking a Senior Safety Scientist to manage the safety management process for clinical trials and post-market activities. The ideal candidate should have at least 5 years of experience in safety and pharmacovigilance, strong analytical skills, and proficiency in safety databases. This role supports remote work and provides opportunities for professional development in a collaborative environment.

Servizi

Professional development

Global travel opportunities

Flexible work programs

Competenze

• 5+ years of Safety and Pharmacovigilance experience required.
• Prior experience processing AE/SAE reports and regulatory submissions.
• Strong command of English required.

Mansioni

• Manage receipt and processing of SAE and UADE reports.
• Perform data entry in the safety database.
• Draft safety narratives and Individual Case Summary Reports.

Conoscenze

Detail-oriented

Organizational skills

Analytical skills

Leadership skills

Communication skills

Formazione

Bachelor of Science in Nursing

Bachelor of Science in Pharmacology

Strumenti

Oracle Argus

ArisGlobal LifeSphere Multivigilance

MS Office Suite

Descrizione del lavoro

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Sr. Safety Scientist is an important member of the Alira Health Clinical team. This person provides technical and process-related support to safety management (clinical trial and post-market) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). The Sr. Safety Scientist is responsible for case receipt, processing, data entry, and query resolution, as well as development of project-specific safety procedures, workflows, and templates. The Sr. Safety Scientist has client-facing responsibilities and provides mentoring to team members. The Sr. Safety Scientist should have experience in multiple therapeutic areas and extensive hands-on safety database experience.

KEY RESPONSABILITIES

Manages the receipt and processing of all serious adverse event (SAE) and unanticipated adverse device effect (UADE) reports from a clinical trial.

Performs accurate data entry of SAE/UADE information in the safety database and tracking systems (Oracle Argus or ArisGlobal LifeSphere Multivigilance preferred).

Reviews SAEs/UADEs for completeness, accuracy, and appropriateness for expedited reporting.

Drafts safety narratives and Individual Case Summary Reports (ICSRs).

Codes adverse events and medical history accurately using MedDRA and codes medications with WHODRUG.

Determines expectedness/ listedness against appropriate label.

Identifies clinically significant information missing from initial reports and ensures its collection.

Initiates, tracks, and resolves requests for follow-up information from clinical sites.

Ensures all cases receive appropriate medical review.

Prepares follow-up correspondence and consults with the medical staff accordingly.

Ensures all cases that require expedited reporting are processed swiftly and appropriately within required timelines.

Provides QC of adverse event reports for other members of the safety team.

Assists in the development of project-specific safety procedures, workflows, and templates.

Assists in project-specific safety database set-up, development of data entry guidelines, and user acceptance testing.

Creates and maintains project-specific working files.

Maintains a strong understanding of safety database conventions .

Works with data management teams on reconciliation of safety data.

Monitors workflow for assigned studies and programs to ensure all deadlines are met.

Along with senior pharmacovigilance team members, prepares Medical Monitoring Plans, Safety Plans, Data Migration Plans, and Pharmacovigilance Plans.

Participates in internal, client/sponsor, and other meetings as required.

Complies with ICH GCP guidelines, FDA regulations, and company SOPs.

Manages and resolve conflicting priorities to deliver on commitments.

Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

BS/BA from an undergraduate program , registered nurse, or an equivalent combination of education and 5 years minimum of Safety and Pharmacovigilance experience.

Prior experience processing AE/SAE reports, generating narratives, generating and resolving safety queries, and experience with regulatory submissions to competent authorities.

Comprehensive understanding of AEs/SAEs and ability to train others to recognize the required standards per ICH GCP guidelines; submit to client; and liaise with other cross functional groups within the agreed/ stated timelines.

Expert level knowledge of global regulatory requirements with experience in the pharmaceutical, biotechnology, or CRO industry, with a preference given to previous experience in a safety department within a CRO.

TECHNICAL COMPETENCES & SOFT SKILLS

Proven ability to be careful, thorough, and detail-oriented.

Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.

Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.

Self-starter who thrives in a collaborative, yet less structured team environment.

A bility to problem-solve unstructured or ambiguous challenges.

Strong command of English, both written and verbal.

Excellent communication and interpersonal skills with customer service orientation.

Proficient with MS Office Suite, particularly Word and Excel.

Permanent a uthorization to work in the U.S.

Ability to work remotely.

Ability to travel occasionally

Languages

English

Education

Bachelor of Science (BS): Nursing, Bachelor of Science (BS): Pharmacology

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Sr. Safety Scientist is an important member of the Alira Health Clinical team. This person provides technical and process-related support to safety management (clinical trial and post-market) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). The Sr. Safety Scientist is responsible for case receipt, processing, data entry, and query resolution, as well as development of project-specific safety procedures, workflows, and templates. The Sr. Safety Scientist has client-facing responsibilities and provides mentoring to team members. The Sr. Safety Scientist should have experience in multiple therapeutic areas and extensive hands-on safety database experience.

KEY RESPONSABILITIES

• Manages the receipt and processing of all serious adverse event (SAE) and unanticipated adverse device effect (UADE) reports from a clinical trial.

• Performs accurate data entry of SAE/UADE information in the safety database and tracking systems (Oracle Argus or ArisGlobal LifeSphere Multivigilance preferred).

• Reviews SAEs/UADEs for completeness, accuracy, and appropriateness for expedited reporting.

• Drafts safety narratives and Individual Case Summary Reports (ICSRs).

• Codes adverse events and medical history accurately using MedDRA and codes medications with WHODRUG.

• Determines expectedness/ listedness against appropriate label.

• Identifies clinically significant information missing from initial reports and ensures its collection.

• Initiates, tracks, and resolves requests for follow-up information from clinical sites.

• Ensures all cases receive appropriate medical review.

• Prepares follow-up correspondence and consults with the medical staff accordingly.

• Ensures all cases that require expedited reporting are processed swiftly and appropriately within required timelines.

• Provides QC of adverse event reports for other members of the safety team.

• Assists in the development of project-specific safety procedures, workflows, and templates.

• Assists in project-specific safety database set-up, development of data entry guidelines, and user acceptance testing.

• Creates and maintains project-specific working files.

• Maintains a strong understanding of safety database conventions .

• Works with data management teams on reconciliation of safety data.

• Monitors workflow for assigned studies and programs to ensure all deadlines are met.

• Along with senior pharmacovigilance team members, prepares Medical Monitoring Plans, Safety Plans, Data Migration Plans, and Pharmacovigilance Plans.

• Participates in internal, client/sponsor, and other meetings as required.

• Complies with ICH GCP guidelines, FDA regulations, and company SOPs.

• Manages and resolve conflicting priorities to deliver on commitments.

• Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

• BS/BA from an undergraduate program , registered nurse, or an equivalent combination of education and 5 years minimum of Safety and Pharmacovigilance experience.

• Prior experience processing AE/SAE reports, generating narratives, generating and resolving safety queries, and experience with regulatory submissions to competent authorities.

• Comprehensive understanding of AEs/SAEs and ability to train others to recognize the required standards per ICH GCP guidelines; submit to client; and liaise with other cross functional groups within the agreed/ stated timelines.

• Expert level knowledge of global regulatory requirements with experience in the pharmaceutical, biotechnology, or CRO industry, with a preference given to previous experience in a safety department within a CRO.

TECHNICAL COMPETENCES & SOFT SKILLS

• Proven ability to be careful, thorough, and detail-oriented.

• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills.

• Self-starter who thrives in a collaborative, yet less structured team environment.

• A bility to problem-solve unstructured or ambiguous challenges.

• Strong command of English, both written and verbal.

• Excellent communication and interpersonal skills with customer service orientation.

• Proficient with MS Office Suite, particularly Word and Excel.

• Permanent a uthorization to work in the U.S.

• Ability to work remotely.

• Ability to travel occasionally

Languages

English

Education

Bachelor of Science (BS): Nursing, Bachelor of Science (BS): Pharmacology

Contract Type

Regular

About Us

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

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