Senior Safety Operations Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

Job Summary:

Gilead Sciences International, Ltd. is seeking a highly skilled Senior Safety Specialist to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of safety and quality.

Key Responsibilities:

  • Perform routine and non-routine daily case management activities independently, providing direction and support to junior staff as needed.
  • Lead training and onboarding activities, ensuring that new team members are equipped with the necessary knowledge and skills to excel in their roles.
  • Lead high-complexity projects, collaborating with cross-functional teams to drive results and achieve business objectives.
  • Participate in cross-functional projects, representing the Pharmacovigilance department at project meetings and ensuring that safety and quality considerations are integrated into project plans.
  • Serve as a point of contact for other functions within and outside the organization, providing expert guidance and support as needed.
  • Develop and assist with quality reviews of data for the applicable functional area, ensuring that all data is accurate, complete, and compliant with regulatory requirements.

Requirements:

  • Excellent interpersonal and communication skills, both written and oral.
  • Excellent computer skills, including proficiency in Microsoft Office and other relevant software applications.
  • A quality-driven individual with strong attention to detail and accuracy, able to work independently and as part of a team.
  • Strong organizational skills, with the ability to adapt to change and prioritize multiple tasks and projects.
  • Safety database and/or data entry experience, with a strong understanding of medical terminology and the ability to summarize medical information.
  • Knowledge and experience with safety reporting and regulatory compliance, including international safety reporting and regulations.
  • Ability to effectively represent the Pharmacovigilance department on multidisciplinary teams, driving results and achieving business objectives.

Education and Experience:

Exempt Professional Leveling Guide:

6+ years with a Bachelor's degree or equivalent

4+ years with a Master's degree or equivalent

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