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Senior Manager, Trial Safety Science

Senior Manager, Trial Safety Science

A global biopharmaceutical corporation located in New Jersey is seeking to hire a Senior Manager of Trial Safety Science for a 12-month contract. Contract extensions will be granted based on performance.

The Senior Manager of Safety Science will be responsible for: 1) Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication. 2) Provides support in activities relating to monitoring and management of Product's emerging safety profile. 3) Assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile. 4) 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, and ICF. 5) May contribute to the content of Aggregate Safety Reports (PSUR/DSUR) and Investigator Brochures in accordance with regulatory requirements and standard operating procedures.

Duration: 12-month contract

Location: Summit, New Jersey

Compensation: hourly rate*

Requirements:

  • Education Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience.
  • Must have relevant industry experience, at least 4-6 years of relevant pharmaceutical industry experience.
  • Previous experience in Safety or Clinical Development or Operations is required.
  • Must have 2-4 years of Drug Safety Experience.
  • Must be a strong decision maker with time management & prioritization capabilities.

Sthree US is acting as an Employment Business in relation to this vacancy.