Skip to content

Job Openings

Director Clinical Safety

Basking Ridge, NJ 07920

Posted: 04/08/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 600701 Is job remote?: No Country: United States

Job Description


Responsibilities:
  • Incumbent will be responsible for responses to Health Authority inquiries on safety issues and prepares safety data for health authority review boards
  • Present safety data in SMTs as a recognized product safety expert and serve as the CSPV functional rep at Global multifunctional project team meetings
  • This position prepares, summarizes, and reviews aggregate safety analyses
  • Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III
  • This position performs safety assessments and determines the safety profiles of assigned products
  • This position also works with other CSPV staff to assess new signals/risks emerging from post marketing data
  • This position may review and approve safety documents
  • Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, SmPC, PI, CSR, Clinical Overview and Integrate safety summary) required during active development, submission phase and during marketing phase
  • Safety Expert - Overall: Serves as the physician responsible for safety profile and for leading SMTs for post marketing safety data from assigned products
  • Defines the risk component of the B/R assessment
  • Safety Expert - Signal Evaluation: Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets
  • Safety Expert - Risk Mitigation & Communication: Supports manager in recommending and implementing risk mitigation activities
  • Proposes risk mitigation solutions to management and SMT Reports and Submissions: Contributes to and reviews safety sections of the NDA, CSR, and IB
Skills:
  • 3-5 years of Pharmacovigilance (PV)/drug safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work
  • Demonstrated ability to prioritize work, implement strategy and processes, collaborate with others

Education:
  • MD Degree Required

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.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, 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.