Senior Safety Specialist

Alira Health; Veneto; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A prominent health consulting firm in Veneto seeks a Senior Safety Specialist to oversee safety management in clinical trials. The ideal candidate will have at least 5 years of relevant experience and strong organizational skills. Responsibilities include managing SAE reports, ensuring compliance with regulations, and drafting safety narratives. This role offers opportunities for professional growth in a dynamic environment.

Competenze

• Minimum 5 years of experience in Safety and Pharmacovigilance.
• Experience processing AE/SAE reports and generating narratives.
• Strong command of English, both written and verbal.

Mansioni

• Manage and process serious adverse event (SAE) reports.
• Draft safety narratives and Individual Case Summary Reports (ICSRs).
• Ensure compliance with ICH GCP guidelines and FDA regulations.

Conoscenze

Attention to detail

Organizational skills

Analytical 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

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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.

Ability 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 authorization to work in the U.S.

Ability to work remotely.

Ability to travel occasionally

Languages

Education

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

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Consulting

Industries

Hospitals and Health Care, Business Consulting and Services, and Pharmaceutical Manufacturing

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