Clinical Safety Specialist

7 days ago


Basking Ridge, New Jersey, United States HireTalent - Diversity Staffing & Recruiting Firm Full time
Job Title: Pharmacovigilance Partner Management, Clinical Safety & Pharmacovigilance (CSPV) Manager

Duration: 12+ Months (Possibility of extension & conversion)

Location: Basking Ridge, NJ

Job Schedule: 1 day Onsite/week – Possibility to go 100% Remote

Job Description:

Key Responsibilities:
  • Manage PV regulatory intelligence and disseminate it to relevant stakeholders.
  • Maintain and support the impact assessment of emerging global regulatory requirements.
  • Collaborate with service providers for Call Center, case processing, and client's products.
  • Support client's CSPV partnerships and contracts, including vendor outsourcing agreements.
  • Manage relationships with Contract Partners involving PV provisions and PV Information Exchange.
  • Provide subject matter expertise on requirements for corrective and preventative actions.
Requirements:
  • PV Operations and Systems, PV Agreements and contracts, and PV regulatory intelligence backgrounds.
  • Experience in field and knowledge of FDA and global regulations, project management, and clinical and safety databases.
  • Effective communication skills within the team, cross-functionally, regionally, and globally.
  • Ability to manage shifting priorities and collaborate across functions.
  • Comprehensive understanding of functional roles for clinical safety and pharmacovigilance.
Education:
  • Bachelor's Degree in Nursing, Pharmacy, Life Sciences, Health Care, or related field.
  • Master's Degree in Life Sciences.
  • PharmD in Life Sciences.

We encourage you to share this opportunity with friends or colleagues who may be a good fit for the role.



  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Clinical Safety Director **Job Summary** Planet Pharma is seeking a highly skilled Clinical Safety Director to join our team. As a key member of our Safety Management Team, you will be responsible for ensuring the safety of our products in development. **Key Responsibilities** * Identify and evaluate safety signals for assigned products in development *...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    The Fountain Group is seeking a seasoned Clinical Safety Scientist Lead to join our team. This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.Key Responsibilities:Proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    Director, Clinical SafetyThe Fountain Group is seeking a seasoned professional to lead our client's clinical safety efforts. As a key member of the Global Product Team, you will be responsible for developing and implementing a comprehensive product safety strategy.Key Responsibilities:Develop and execute a product safety strategy that aligns with regulatory...


  • Basking Ridge, New Jersey, United States Actalent Full time

    Job Title: Director, Clinical SafetyAbout the RoleThe Director, Clinical Safety will be a key member of our team, responsible for ensuring the safety of our products throughout their lifecycle. This role involves leading safety surveillance and risk management efforts, providing safety leadership, and collaborating with cross-functional teams to...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    Job Title: Associate Director - Clinical Safety ScientistJob Schedule: The ideal candidate will be local and able to work in the office 1-2 days a week. Global Travel ~ 20% of Time. Pay rate: $100/Hr.Responsibilities & Job DetailsThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs,...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    The Fountain Group is currently in search of a Lead Clinical Safety Scientist for a significant client. This role is designed for a professional with expertise in clinical safety and risk management. Below are the details for this opportunity:Work Arrangement: The manager prefers candidates who can be onsite 1-2 days per week.Travel Requirements: Global...


  • Basking Ridge, New Jersey, United States Planet-Pharma Full time

    Job Title: Associate Director Clinical Safety ScientistPlanet-Pharma is seeking an experienced Associate Director Clinical Safety Scientist to lead our safety surveillance and risk management efforts for late-stage programs and early-stage programs.Key Responsibilities:Proactively perform safety surveillance and risk management in partnership with...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job Title: Associate Director Clinical Safety ScientistThis role serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.The...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Clinical Safety ScientistJob Summary:We are seeking an experienced Associate Director, Clinical Safety Scientist to join our team at Daiichi Sankyo, Inc. in Basking Ridge, NJ. As a key member of our Clinical Safety team, you will be responsible for proactively performing safety surveillance and risk management in support of the...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Clinical Safety ScientistJob Summary:We are seeking an experienced Associate Director, Clinical Safety Scientist to join our team at Daiichi Sankyo, Inc. in Basking Ridge, NJ. As a key member of our Clinical Safety team, you will be responsible for proactively performing safety surveillance and risk management in support of the...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    The Fountain Group is seeking a seasoned professional to fill the role of Director, Clinical Safety. This position is a key member of our team and will be responsible for leading our product safety strategy.Key Responsibilities:Develop and implement a comprehensive product safety strategy to ensure the safe development and marketing of our pharmaceutical...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Clinical Safety Scientist Lead to join our team at Planet Pharma. As a key member of our safety team, you will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.Key...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job Summary:Planet Pharma is seeking an experienced Associate Director, Clinical Safety MD to join our team. As a key member of our Safety Management Team, you will be responsible for supporting safety monitoring and risk management activities for products in development.Key Responsibilities:Signal Identification and Evaluation: Conduct routine signal...


  • Basking Ridge, New Jersey, United States The Fountain Group Full time

    The Fountain Group is seeking a seasoned Clinical Safety Scientist Lead to join our team. This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.Job Summary: The Clinical Safety Scientist Lead will serve as the lead for a large, late-stage program or multiple early-stage programs,...


  • Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job Title: Medical Safety DirectorPlanet Pharma is seeking a highly skilled Medical Safety Director to lead our Medical Safety team. As a key member of our organization, you will provide leadership, line management, and mentorship for junior Medical Safety Scientists.Key Responsibilities:Lead cross-functional safety management teams and drive safety strategy...


  • Basking Ridge, New Jersey, United States Proclinical Staffing Full time

    Senior Manager, Clinical Study LeadProclinical is seeking a Senior Manager, Clinical Study Lead to oversee and manage clinical study operations.Key Responsibilities:Develop and manage study-specific documentation, ensuring compliance with regulatory requirements.Supervise the setup and maintenance of study systems, including CTMS and TMF.Ensure compliance...


  • Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals, Inc Full time

    Job SummaryWe are seeking a highly experienced and skilled Associate Director to join our Oncology Clinical Development department at Regeneron Pharmaceuticals, Inc. The successful candidate will lead in the development, evaluation, planning, and execution of clinical studies and ensure scientific integrity and interpretation of study data of a clinical...


  • Basking Ridge, New Jersey, United States Cpl Life Sciences US Full time

    Company OverviewCpl Life Science collaborates with a prominent biotechnology firm dedicated to developing transformative medications for individuals facing severe health challenges. Renowned for its extensive pipeline of pioneering therapies and dedication to scientific integrity, this organization has gained international recognition for its significant...


  • Basking Ridge, New Jersey, United States FellowshipLIFE, Inc. Full time

    About the RoleFellowshipLIFE, Inc. is seeking a highly skilled and compassionate Physician - Internal Medicine Specialist to join our team of dedicated healthcare professionals. As a key member of our medical staff, you will have the opportunity to provide exceptional patient care to older adults in a state-of-the-art medical environment.Key...


  • Basking Ridge, New Jersey, United States Cpl Life Sciences US Full time

    Company OverviewCpl Life Science collaborates with a prominent biotechnology firm dedicated to developing life-changing therapies for individuals facing serious health challenges. Renowned for its extensive portfolio of pioneering treatments and dedication to scientific advancement, this organization has gained international recognition for its significant...