Senior Manager, Trial Safety- Summit NJ 07901

Senior Manager, Trial Safety- Summit NJ 07901

Req CELGJP00007989

 

Preferred skills: A unique blend of prior clinical development/CRA/trial management with some safety experience is best desirable. Ideal candidates have a pharmacy or nursing degree.

General Responsibilities:

Provides support to LPSP in activities relating to monitoring and management of Product's

emerging safety profile

Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting

(PSRM) meetings, maintains roster, calendar, and minutes/communication

May contribute to preparation of materials (Slides, etc.) in preparation of CSC meetings

Contributes to signal detection activities by supporting review and synthesis of key safety

information; Contributes to signal evaluation and tracking

Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global

safety database as well as literature, and assist the Lead Product Safety Physician in determining

the impact of the safety issue on the product¿s benefit/risk profile

Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g.

Legal, clinical, RA, etc.)

May provide input and support safety publication strategy Trial Safety Support

Leads execution of all operational safety-related clinical trial activities, and may serve as the

Lead Safety Scientist for a compound

Supports/May lead the strategy for surveillance activities, as appropriate

Participates in ongoing SAE reconciliation between the safety and clinical databases

Completes study-level activities generation of Case Management Work aids, safety sections of

the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF

Generates SAE report form, pregnancy report form, completion guidelines for trial-related activities

Coordinates the management and preparation for DMC preparation, documentation, and logistical

Support. May review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables,

listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR

 

May contribute to the content of Aggregate Safety Reports (PSUR/DSUR) and Investigator

Brochures in accordance with regulatory requirements and standard operating procedures

Obtains integrated safety outputs by analyzing data from the clinical trial and global safety

database as well as literature, in conjunction with the lead product safety physician for a

compound

May support the lead product safety physician with the management of the products benefit/risk

profile

 

Qualifications/Experience:

 

Education Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience

Relevant Industry Experience At least 4-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.

Drug Safety Experience 2-4 yrs

 

 

 

 

 

 

 

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll 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 career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

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