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Senior Manager, Clinical Safety Scientist

Basking Ridge, NJ 07920

Posted: 08/09/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 569966 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 60-80/hr **salary will be commensurate with experience 

Job Summary:
  • Position independently handles aspects of signal identification, evaluation, and risk mitigation across therapeutic areas.
  • This position proactively creates communication plans for important safety topics and identified risks.
  • Additionally, this position may serve as primary author for certain safety documents and regulatory submissions and reviews protocols and ICFs.
  • Additionally, this position project manages larger Phase 3 or 4 SMTs and supervises junior scientist project managing smaller SMTs.
  • This position works closely with CSPV staff, SMT members, and occasionally IPT members and other functions.
  • Finally, this position works on the most complex problems and makes decisions regarding project management work within CSPV.

Responsibilities:

Risk Management (Signal identification, evaluation, mitigation):
  • Is a key participant in developing, and possibly implementing, the risk management strategy for assigned products/ TAs.
  • Demonstrates familiarity with PV/Epi related literature.
  • Assists CS physician in assessing new signals.
  • May independently integrate and analyze safety data from multiple sources to deliver comprehensive conclusions.

Safety Communication:
  • Develops strategy for communicating safety information internally and externally with CS physician.
  • May first author safety communications.

Documentation:
  • Documents meeting discussions, decisions, action items, and SMT activities independently.
  • Ensures the appropriate archiving of the team meeting documentation and SMT activities independently.
  • Maintains a current signal tracking log independently.

Project Management:
  • Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline.
  • Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately.
  • Coaches, mentors, and influences junior scientists and team members.
Skills:
  • Possesses strong medical or TA and drug development knowledge
  • 6 or more years pharma-related experience with an advanced degree
Education:
  • Bachelor's Degree required
  • PharmD/PhD preferred


**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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