Manager, Safety Evaluation & Risk Management

Manager, Safety Evaluation & Risk Management

21 Sep 2024
Washington, Bothell 00000 Bothell USA

Manager, Safety Evaluation & Risk Management

Vacancy expired!

Type : Contract

Category : Scientific & Clinical

Job ID : 155718

Date Posted : 09 / 08 / 2020

Job Title : Manager, Safety Evaluation & Risk Management

Contract Length : 6 mos

Number of Openings : 1

Job Description :

This position will be responsible for supporting the SERM Program Lead or assigned Risk lead in the signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned CLIENT, investigational and / or marketed products.

The successful candidate will serve as a member of the Patient Safety department and function in a company matrix team environment interacting with several key internal & external (i.

e. partners) stakeholder groups including; Development-Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.

Responsibilities :

May represent Drug Safety in Clinical Sub Team and Study teams for assigned investigational products providing expert medical guidance regarding safety issues

Review and provide analysis for the support of key study-related documents, e.g. IB, ICF, SMC / IDMC with guidance from SERM Risk lead or Program lead

Provide assistance in protocol development to ensure alignment with the current development product adverse event profile, risk management plans and effective collection of safety data

Support other program-level activities, such as pre-BLA preparation of documents, safety deliverables (SCS, ADR tables, etc) as assigned, and program-specific data quality assessments

Support inspections and audits

Participate in the Signal Management System with supervision from the SERM Risk lead or Program Lead, with regular review of safety data for assigned products for identification and evaluation of new safety signals

Help safety data review to include individual case review and aggregate safety assessment and analysis using safety data from clinical trials or post-marketing sources with guidance from SERM Risk lead or Program lead

May aid in medical review of individual safety reports from clinical trials or post-marketing sources with guidance from SERM Risk lead or Program lead

Contribute to preparation and review of periodic reports (PADER; DSUR; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report)

Participate in production and maintenance of risk management plans and safety communication to regulatory agencies or third parties (marketing applications, company core safety information, regulatory safety queries, etc.

with guidance from SERM Risk lead or Program lead

May represent SERM in data standards committee

May mentor other Patient Safety Team members, or new hires in SERM

Qualifications :

Pharm D, Ph.D, MD (board certified / board eligible or ex-US equivalent)

Proficiency in use of Excel, Microsoft Office and PowerPoint

Some working knowledge of Safety-relevant software (e.g. Spotfire, J-Review)

Some working knowledge of Safety related databases (e.g. Argus)

Minimum 2 years of relevant safety pharmacovigilance training in a pharmaceutical company. Oncology safety science experience preferred

Clinical research experience desired

Exposure to clinical data collection, assessment and analysis

Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally

Excellent written and spoken English

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Job Details

  • ID
    JC4852627
  • State
  • City
  • Full-time
  • Salary
    N/A
  • Hiring Company
    System One Services
  • Date
    2020-09-08
  • Deadline
    2020-11-07
  • Category

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