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Manager - PV Science

Edison-New Brunswick Metro Area, NJ

Posted: 11/25/2019 Job Type: Scientific Job Number: JN -112019-26033

Job Description

PV Scientist - Prior clinical development/CRA/trial management with some safety experience


JOB DESCRIPTION:

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 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 product s 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 /


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 2-6 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.


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