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13 days old

Safety Scientist IV

Kelly Services
San Francisco, CA 94103
**Job Title:** Safety Scientist IV



**Duties:**

The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products. This may include single case medical review, aggregate reporting, signal detection and evaluation, and other safety related activities e.g. associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management. The Safety Scientist supports the Safety Science Leader and is responsible for a particular aspect(s) or segments of the overall program or a group of products.




**Responsibilities:**




+ Carry out pharmacovigilance and risk management activities for specific product or products: Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues

+ Support the preparation and maintenance of Risk Management plans

+ Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures

+ Support the preparation and maintenance of safety sections of the Company Core Data Sheet Lead/support PDS post-marketing safety study activities

+ Coordinate safety activities between PDS and internal and external partners

+ Carry out signal detection activities and evaluation: Conduct/support signal detection and evaluation according to SOPs and guidelines

+ Carry out medical review of individual case safety reports (ICSRs), if assigned for the product according to SOPs and guidelines

+ Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)

+ Respond to safety requests for the assigned product from regulatory agencies or affiliates/ other internal functions

+ Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products: Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP

+ Contribute to regulatory agency submissions (IND applications, NDAs, MAAs, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages

+ Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable

+ The Safety Scientist should develop a clear understanding of the safety issues and a thorough knowledge of the from the drug mode of action, to enable support the SSL

+ The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP) and develop an understanding of the safety profile of the assigned product

+ Whenever assigned by the SSL, the Safety Scientist is responsible for the development and whenever appropriates the execution of RMP or REMS risk mitigation tactics.



**Education/Qualifications Minimum:**




+ PhD, PharmD, Pharm, MS or equivalent qualification

+ Strongly desired: MD, PhD or PharmD

+ Bioscience Degree



**Experience, Skills, Knowledge:**




+ Prior industry experience in drug safety, clinical development or medical affairs is desirable

+ MD candidates - clinical practice experience (at least 3 years preferred, may include residency)

+ Good knowledge of pharmacovigilance practices

+ Good knowledge of US and EU pharmacovigilance regulatory requirements

+ Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions

+ Ability to evaluate, interpret and synthesize scientific data (analytical thinking)

+ Team player with ability to function in a multi-disciplinary environment

+ Self-motivated, able to prioritize and plan effectively

+ Attention to detail

+ Fluent in English (verbal and written)

+ Good negotiating and influencing skills

+ Good computing/IT skills



JOB TITLE:Safety Scientist IV

JOB DESCRIPTION:Req#:

9491974

Client:

Genentech

Manager:

Date Start:

11/04/2019

Type: Contractor - Staffing

Dept:

4748 : Safety Sci Delivery

Supplier:

Date End:

05/01/2020

Requisition Status: Pending

Worker:

General Info

Resume/Portfolio | Interview

Default View Expand All Collapse All

Description

Requisition Status: Pending

Status Reason: Pending Headcount Approval

Pending Sourcing

Reason: Peak Period

Reason Detail:

Manager:

Department: 4748 : Safety Sci Delivery

Product Dev Functs : Global Development : PD Drug Safety : Safety Onc (PDSS)

Job Category: Drug Devt - Med/Clin Affairs

Job Code: Safety Scientist IV:Safety Scientist IV

Job Title: Safety Scientist IV

Keywords:

Number of Positions: 1

Remaining Positions: 1







Languages:

English Read Write Speak

Certifications & Licenses:

CSSD

Attachments: SafetyScientistJD_prounlimitedCL.pdf

Skills and Experience

Skills:

Required

CLINICAL SAFETYDATA ANALYSISDATA SOURCESDRUG SAFETYDVM

Additional

FILINGSLIFE SCIENCESPHARMDPRODUCT LIFECYCLERISK MANAGEMENTSSLTRAININGCLINICAL TRIALDSCDUE DILIGENCEEXCELLENT WRITTENEXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLSFILINGGDTGOVERNANCEGXPJOURNALMAINTENANCEMARKETINGMARKETING ANALYSISMITIGATIONPDSPHARMACOVIGILANCEPRODUCT DEVELOPMENTPUBLISHINGRISK ASSESSMENTSSAFETY MANAGEMENTTRADING

Languages:

English( Speak, Read, Write )

Minimum Degree Required:

Also Preferred:

Location

Work Performed

Onsite:

State/Province: California

City/Town: South San Francisco

Address: 600 East Grand Avenue, SSF40

Schedule

Start Date: 11/04/2019 Hours Per Week: 40.00

Est. End Date: 05/01/2020 Hours Per Day: 8.00

Schedule Notes: Days Per Week: 5.00

Financials

Department: 4748 : Safety Sci Delivery

Product Dev Functs : Global Development : PD Drug Safety : Safety Onc (PDSS)

Rate Application: Per Hour

Currency: USD

Supplier FLSA Classification: N/A

Contact Information

MSP Contact: Chhi, Jessica Additional Contact:

MSP Phone: Additional Phone:

HR Contact: Additional Email:

Supplier Notes Contacts

Custom Fields

Travel Required: No Is this contractor working in a GMP environment?: No

Second Job Title: Safety Scientist Function: PD

Dates of Interest

Date Created: 10/25/2019 Date Closed:

Date Pending: 10/25/2019 Date Cancelled:






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-01 Expires: 2019-12-02

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Safety Scientist IV

Kelly Services
San Francisco, CA 94103

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