Senior Specialist Clinical Safety

AmerisourceBergen; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Senior Clinical Safety Specialist to enhance health outcomes through effective management of adverse events in clinical trials. This role involves ensuring compliance with safety regulations, managing data entry in specialized databases, and supporting the Clinical Safety Lead in safety management plans. The ideal candidate will possess strong organizational skills, a team-oriented mindset, and a commitment to quality and safety in pharmacovigilance. Join a forward-thinking team dedicated to improving lives and making a significant impact in the field of health.

Qualifications

• 1+ year of experience in Pharmacovigilance and case management.
• Knowledge of safety databases and MedDRA coding.

Responsibilities

• Manage Serious Adverse Events and reporting processes.
• Support Clinical Safety Lead in developing Safety Management Plans.

Skills

Team-oriented approach

Organizational skills

Self-motivation

Fluent English skills

Excellent communication skills

Education

Bachelor’s degree in medical sciences

Tools

Argus

Safety Easy

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

We have an exciting opportunity for a Senior Clinical Safety Specialist to join our team in Spain!

The role will include:

1. Management of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) process: receipt, data entry, narrative writing, request follow-up, request medical assessment, and expedited or aggregate reporting.
2. Data entry and quality control of adverse event reports in databases such as ABCube Safety-Easy and Argus.
3. MedDRA coding of Adverse Events.
4. Reporting of reports that meet criteria for expedited reporting via validated E2B compliant safety database or through the EMA reporting tool EVWEB for ICSRs and SUSARs.
5. Reconciliation between the SAEs and the clinical study database.
6. Supporting the Clinical Safety Lead in designing and developing Safety Management Plans for clinical trials.
7. Writing and submitting Development Safety Update Reports (DSUR) under supervision.
8. Reviewing legislation related to Pharmacovigilance Regulatory Intelligence (PV-RI) for clinical trials.
9. Supporting preparation for internal and external audits/inspections and responding to requests.

The employee agrees to take on primary tasks and responsibilities across other service lines, engage in project management activities as a client contact point, and perform additional reasonable tasks that align with their abilities, qualifications, and training, if required.

Skills

• Team-oriented approach
• Organizational skills and ability to multi-task, analyze information rapidly
• High sense of responsibility and self-motivation
• Highly service-oriented
• Flexibility and adaptability to new, unknown, challenging situations
• Fluent written and spoken English skills
• Excellent communication skills

Experience/Background

• Bachelor’s degree in medical, natural sciences, pharmacy-related field, or Medicine
• At least 1 year of relevant professional experience in Pharmacovigilance
• Knowledge of safety databases such as Argus and Safety Easy
• Experience in case management activities
• Previous experience in pre-authorisation areas

What Cencora Offers

Benefits outside the US may vary by country and will be aligned with local market practices. Eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Additional Information

Full-time employment with affiliated companies: PharmaLex Spain S.L.U.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any protected class by law.

We are dedicated to utilizing qualified individuals fully and effectively. Harassment is prohibited, and all employment practices comply with equal opportunity principles and are non-discriminatory.

We provide reasonable accommodations for individuals with disabilities during the employment process. To request an accommodation, contact us at 888.692.2272 or [e-mail]. Accommodation requests will be handled on a case-by-case basis. Messages unrelated to accommodation requests will not be responded to.