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Drug Safety Manager

Edison-New Brunswick Metro Area, NJ

Posted: 10/30/2018 Job Type: Clinical Job Number: JN -102018-22930
Position: Senior Manager, Safety Science
Education Pharmacy/Nursing (e.g., BS, MS, BSN/RN, PharmD) or other degree with the equivalent combination of relevant education and professional experience
Relevant Industry Experience At least 2-4 years of relevant pharmaceutical industry experience. Previous experience in Safety or Clinical Development or Operations is required.


Provides support to 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
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