Celgene Safety Information Analyst (temporary contract 1 year) in MARIN, NebraskaSwitzerland

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope:

The Safety Information Analyst is responsible for managing distribution of safety information (e.g. SUSARs, 6 monthly line listings, DSUR, lay summary) in support of all Celgene clinical trials managed by GTMM and/or delegated to a Contract Research Organization (CRO) on behalf of Celgene.

The SIA will interact with clinical trial sites, central IRB/EC, CROs/vendors, and the cross-functional study team.

Responsibilities may include, but are not limited to the following:

  1. Manage and triage inquiries received via centralized mailbox and mitigate

user/system performance issues or escalate as necessary

  1. Manage content and functionality of databases and shared working space

(e.g. CelAlert, Country Requirements) in support of maintaining safety

information for clinical trials

  1. Review of national guidelines for EC reporting requirements, ensuring

regulatory compliance with regards to safety reporting

  1. Ensure consistency and accuracy of safety information and reporting

requirements for EU and ROW through periodic checks to identify issues;

resolves issues through data verification and reporting improvement efforts

reconcile information received and distributed

  1. Distribute relevant documentation to investigational sites, ECs, or vendors as

per requirements and distribute communications and study documents to

study teams.

  1. Maintain oversight of TMF for related documents including routine QC

  2. Support site training via portal or other platform (e.g. CelAlert, pregnancy

prevention, GCP)

  1. Create and manage training content for internal and external users, as

appropriate

  1. Primary point of contact for business user community to provide day to day

support of system(s) used to support process.

10.Subject matter expert on use of clinical system/portal, functional capabilities

and relevant business processes enabled by the system.

11.Liaise with vendors as appropriate (e.g. portal platform, printing, translations)

12.Contribute to development of procedural documents and continual process

improvement

13.Perform all other duties as assigned.

Qualifications

Prequisites:

• BA / BS Degree or equivalent in relevant discipline

• Minimum 2 years safety reporting and/or clinical study management experience

Skills/Knowledge Required:

• Strong organizational skills and attention to detail

• Self-motivated and proactive learner

• Works well independently and in a team

• Able to prioritize, demonstrate flexibility

• Strong oral and written command of English language

• Strong communication skills

• Strong problem-solving skills

• Strong command of computerized systems, databases, etc.

• Familiarity with drug development process, ICH/GCP and global regulatory guidelines/directives

• Cross cultural awareness

Key Leadership Competencies:

• Places a priority on getting results with an emphasis on high quality outcomes

• Holds self and others accountable for accomplishing goals

• Makes timely, data-driven decisions

• Develops and maintains effective working relationships with people across cultures

• Demonstrates sense of urgency in response to customers

• Ensures that conflict is handled constructively so that performance is not impacted

• Displays a willingness to challenge the status quo and take risks

• Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute

• Maintains optimism and composure in times of change, uncertainty, or stress

Safety Information Analyst (temporary contract 1 year)

Location: MARIN, NE, CH

Job ID: 17001797