Celgene hiring for Specialist, Drug Safety

Celgene

Specialist, Drug Safety
Greater New York City Area, US - Biotechnology, Pharmaceuticals, Research
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.

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

AE CASE MANAGEMENT
Receipt
- Execute receipt of Drug Safety phone calls and complete telephone AE form

- Create phone call communication logs in ARISg

Triage
- Support the triage of cases conducted by Snr Specialist as needed

Assessment - Complex Case
- Support the assessment of complex cases conducted by Snr Specialist as needed

Assessment - Non-Complex Case
- Execute QC on key fields of serious cases

- Create key fields updates in ARISg based on QC, as needed

- Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)

- Create auto-narrative as needed

- Review & update auto-narrative as needed

- Create draft company comments for serious cases

- Develop event rankings

- Create dechallenge / rechallange determinations

- Develop follow-up needs for AE reports

- Create auto-populated follow-up letters

- Review and update generated follow-up letters as appropriate

- Authorise (approve) non-serious cases (except cases of special interest)

- Create major modifications following Medical Review

Medical Review
- Support the identification of corrections and creation of updates in ARISg following medical review

PHARMACOVIGILANCE (APPROVED PRODUCTS)
PSURs
- Update AE reports within safety database to support line listings

COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT
Preparation for Regulatory Inspection
- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

INTERNAL GLOBAL SAFETY DEPARTMENT DEVELOPMENT
- Participate in product meetings within the drug safety department

- Contribute to the hiring, orientation, training and development of staff as needed

Qualifications
Qualifications
- Minimum of B.S. or the equivalent combination of relevant education or professional experience

- Current registered medical license preferred

Experience
- Two (2) years relevant clinical experience

Knowledge
- Clinical knowledge of therapeutic area patient populations and drug class

- Computer and database skills preferred

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.



Req ID: 15000995
Primary Location: United States-New Jersey-Berkeley Heights
Job: Quality
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2015-04-30 00:00:00.0


No salary provided

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Posted May 01, 2015 at 02:00PM