11 days old

Senior Manager, Trial Safety- Summit NJ 07901

Kelly Services
Summit, NJ 07901
Senior Manager, Trial Safety Science- Summit, NJ 07901

Requirement: 7337

Supervisor: Director/Senior Director, Safety Science

Department: Global Drug Safety & Risk Management

Key Responsibilities will include, but are not limited to, the following:

+ 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 products 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 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 product benefit/risk profile

Departmental Activities:

+ Supports preparation for regulatory inspections with evaluation of current processes and

Documentation. Liaises with all TA staff and maintain an effective and collaborative product safety team. Supports hiring, orientation, management, mentorship, and development of staff

+ Cross-Functional Activities: Provides safety training to site and study personnel, and responds to ad hoc Investigator / IRB /EC Queries

+ Supports various process improvement and cross-functional initiatives for both Safety Science

and GDRSM, which may include input to the development and periodic update of SOPs and

Work Practices

+ Interacts with key line functions in support of safety activities between Safety Science and

clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety

Information Management

Key Relationships

+ Department staff, peers and management

+ Lead Product Safety Physicians

+ Clinical Operations

+ Data Management

+ Clinical Research Scientists

+ Medical Writing

+ Case Management / LDSO

+ Global Medical Affairs

+ Regulatory Affairs

+ Clinical Quality Assurance


Participate and/or provide input to materials and strategies at meetings including but not limited

to: SMT - Safety Management Teams, DMC - Data Monitoring Committees, internal or external Clinical Study Team


+ 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 years

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

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000
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.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-02-11 Expires: 2019-03-14

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Senior Manager, Trial Safety- Summit NJ 07901

Kelly Services
Summit, NJ 07901

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