Sr. Pharmacovigilance Scientist, Safety and Benefit Risk - Biogen Idec - Cambridge, MA

The PV Scientist assists and supports the ongoing aggregate review and analysis of product safety data to support the product life cycle for assigned molecules, both pre and post-marketing. Such tasks include preparation and authoring of aggregate safety data including signaling reports, PSURs (Periodic Safety Update Reports), Annual Safety Reports, and reports to support internal/external data safety monitoring boards. The PV Scientist will also support Risk Evaluation and Mitigation Strategy (REMS) plans, Pharmacovigilance Plans, EU Risk Management Plans, product recalls, and other safety surveillance activities. The PV Scientist will author and assist in signal evaluations and the management of responses to regulatory agencies related to the assigned product.

Location
US-MA-Cambridge

Job Category
Drug Safety

Requisition Number
20875BR

Qualifications
Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology.
Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues for partnered
Develops and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
Excellent written and verbal communication skills. Demonstrated presentation skills.
Extensive medical writing, editing, and source document review.
Clinical judgment, ability to interpret case information
Knowledge of drug development process.
Basic knowledge of applicable clinical trial safety regulations and postmarketing regulations.
Demonstrated ability to independently manage complex projects with multidisciplinary teams
Medical writing, editing, and source document review.
Clinical judgment, ability to interpret case information
Basic medical literature search skills.
Strong organizational skills, including the ability to prioritize independently with minimal supervision.
Ability to adapt to a rapidly changing environment
Proven ability to evaluate. clinical and epidemiologic data
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Knowledge of common safety database systems
Minimum 3 years relevant experience (including industry experience) with familiarity with industry principles of drug safety, drug development, regulatory, pharmacology, and pharmacoepidemiology.

Education
Academic degree in biological or natural science or health care discipline (e.g. PhD, MPH, NP, Pharm D, MSc).
Biogen Idec - 4 days ago - save job - block

Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers medecines to improve the lives of patients. As a...

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MEDICAL HEALTH INSURANCE POSITIONS - SA - Benefit Recovery - San Antonio, TX

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September 10, 2010 (last updated 30+ days ago)

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MEDICAL HEALTH INSURANCE POSITIONS
-Posting/Billing Specialist (Must have direct work experience)

-Follow-Up Specialist (Must have direct work experience)

-Denials Management/Appeals Specialist (Must have direct work experience)

Benefit Recovery is currently searching for outgoing, self-starting, multi-taskers for a health insurance Posting Specialist, Follow-Up Specialist, or Denials Management Specialist. The positions are located in San Antonio, TX. Candidates must be computer literate, and type at least 35 wpm. High School diploma or equivalent is required.

As a Posting/Billing Specialist, you must have at least 1 year of direct posting or billing/coding work experience in the healthcare industry, must have accounts receivable and/or accounts payable experience, and must have existing knowledge of medical terminology.

As a Follow-Up Specialist, you must have at least 1 year of direct follow-up experience in the healthcare industry, must be able to request claim status, reprint and resubmit corrected claims to payors, call and verify health insurance, and must have existing knowledge of medical terminology.

As a Denials Management/Appeals Specialist, you must have at least 1 year work experience managing denied claims and/or filing health insurance appeals and must be able to construct appeal letters. Must have experience following up on health insurance claims as well as denied claims, and have existing knowledge of medical terminology.

Candidates must be able to successfully pass a criminal investigation and must be able to pass a credit check. Your credit must be in good standing and have no current delinquent, past due, or collectable debt.

Good communication skills are essential. All candidates must have the ability to communicate effectively with a positive and pleasant attitude during interaction with colleagues, hospital staff, patients, public, and physicians and their staff. Knowledge of HIPAA, TPOCS, UB92, HCFA1500, ICD-9 forms and CPT codes is preferred.

If you are currently working in a physician's office, hospital, medical insurance claims or billing hub and are looking for a change, consider joining our dynamic and expanding company.

Benefit Recovery has been in operation since 1992. We have 35 locations in 22 different states with corporate headquarters in Houston, Texas. Our clients consist of commercial hospitals, hospital corporations, Veterans Administration medical centers, and the United States Air Force medical treatment facilities. The main business operation is geared toward the recovery of denied hospital claims from health insurance carriers. We also offer our clients services such as insurance verification, pre-registration, and outpatient billing.

Visit our web site at w.Benefitrecovery

If you meet the requirements, please apply online. Others will not be considered. Inquiries without salary requirements will not be considered. We will select and contact those applicants that most closely match our requirements. No phone calls please.

We are an Equal Opportunity Affirmative Action employer.

Industries: Financial Services

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