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Job Details

Pharmacovigilance Sr. Scientist

Company name
Sunrise Systems Inc,


Thousand Oaks, CA

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Our client, a leading fortune company is looking for Pharmacovigilance Sr. Scientist .This is for an initial duration of 12 months located in Thousand Oaks, CA.

Top Skill Sets:

Conduct signal detection, evaluation, and management.

Perform data analysis to evaluate safety signals and write up analysis results in collaboration with Global Safety Officer (GSO).

Prepare safety assessment reports and other safety documents and regulatory responses


RN, PharmD or PA Clinical/medical research experience Processes and regulations for pharmacovigilance and risk management Aggregate data analysis, interpretation and synthesis Signal detection, evaluation and management 6 years of experience in a biotech/pharmaceutical setting

Job Summary:

The PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

Key Activities:

Applicable tasks may vary by product(s) assigned. The PV Sr. Scientist is responsible for the following:

Planning, preparation, writing and review of portions of aggregate reports

Organize and direct liaison for activities with affiliates and other internal partner regarding products

Supports and provides oversight to staff with regards to safety in clinical trials to:

Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents

Review of AEs/SAEs from clinical trials as needed

Review standard design of tables, figures, and listings for safety data from clinical studies

Participate in development of safety-related data collection forms for clinical studies

Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results

Documents work as required in the safety information management system

Support authoring of Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO

Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection

Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body

Assist GSO in the development of risk management strategy and activities:

Provides contents for risk management plans

Develop or update strategy and content for regional risk management plans

Assist GSOs to oversee risk minimization activities including tracking of activities as needed.

Evaluate risk minimization activity

Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO

Support activities related to new drug applications and other regulatory filings

Assist GSO in developing a strategy for safety-related regulatory activities

Provide safety contents for filings Inspection Readiness

Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Knowledge and Skills:

Processes and regulations for pharmacovigilance and risk management

Drug development and lifecycle management

Safety data capture in clinical development and post-market settings

Safety database structure and conventions

MedDRA and other dictionaries used in pharmacovigilance

Methods of qualitative and quantitative safety data analysis

Product and disease state knowledge

Risk management and risk minimization

Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

Advanced understanding of interfaces across various pharmacovigilance and risk management processes

Internal organizational and governance structure Pharmacovigilance skills-intermediate knowledge of the following:

Signal detection, evaluation and management

Aggregate data analysis, interpretation and synthesis

Good clinical and scientific judgment

Application of medical concepts and terminology

Document writing and source document review

Writing Risk Management Plans

Ability to convey complex, scientific data in an understandable way

Ability to analyze and interpret complex safety data

Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance

Biomedical Literature-intermediate skills:

Literature Surveillance: source document review knowledge and skills

Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills

Education & Experience (Basic):

Doctorate degree and 2 years of directly related experience OR

Master's degree and 6 years of directly related experience OR

Bachelor's degree and 8 years of directly related experience OR

Associate's degree and 10 years of directly related experience OR

High school diploma / GED and 12 years of directly related experience Education & Experience

Qualified candidates please send your word format updated resume at the earliest , Thank You!

Experience Level:




Thousand Oaks CA


12 months

Pay Rate:


Company Profile
Sunrise Systems was founded in 1990 and has since evolved into a leading professional Services and Solutions firm specializing in the areas of Staffing, Information Technology development, and IT Consulting services. With over 20 years of industry experience, we at Sunrise Systems pride ourselves on our flexible engagement models, designed to cater to our clients’ Staffing, Consulting, and Technology needs. Over the years, Sunrise has built a strong talent pool with a wide range of experienced IT professionals. With our proven placement strategy, we offer clients unparalleled project management experience, technical expertise, and industry-specific acumen, as well as the right professionals to fit any unique company culture.

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