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Senior Manager / Associate Director, Trial Safety Science

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -012020-26306 Region: Newark Metro Area

Job Description

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 product s benefit/risk profile


KNOWLEDGE/SKILLS/ABILITIES (KSA s):

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 (SENIOR MANAGER) OR 6-8 years (ASSOCIATE DIRECTOR) of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.

Drug Safety Experience 2-4 yrs (SENIOR MANAGER); at least 4 years (ASSOCIATE DIRECTOR)

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