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10 Dec. 11, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Manager
Location: Not Specified
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Job Description:

Join Thermo Fisher Scientific Inc. as a Pharmacovigilance Manager and play a critical role in ensuring patient safety while working in an innovative and collaborative environment. This opportunity allows you to support exceptional research initiatives and be part of a team dedicated to making a global impact on patient care and safety.

Job Responsibilities:

Discover Impactful Work:

  • Manage contracted safety responsibilities for multiple programs, overseeing staffing, training, and procedural compliance.
  • Lead the safety team for respective programs and ensure the development of internal processes aligned with best practices.
  • Collaborate with senior management and liaise proactively with Project Managers and clients to optimize safety project team performance.

A Day in the Life:

  • Monitor and evaluate risks to pharmacovigilance (PV) project deliverables and finances; propose effective mitigation strategies.
  • Serve as the primary point of contact for clients, managing relationships and communication.
  • Oversee financial stewardship, guiding decisions for project scope increases and driving profitability.
  • Drive timelines and tasks related to safety reporting PV functions, ensuring deadlines and deliverables are met.
  • Lead operational, tactical, and governance calls with clients.
  • Prepare for and attend client audits and inspections.
  • Maintain coordination with other teams regarding project issues and topics.
  • Generate key performance metrics for projects, such as key performance indicators and volumes.
  • Oversee the budget for assigned projects, collaborating with teams on contract management and renewals.
  • Lead internal financial and project review meetings.
  • Ensure collaboration across all PV functions to meet agreed project targets.
  • Drive departmental initiatives for continuous improvement.

Education:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualifications.
  • 3+ years of safety experience, with a minimum of 8 years of relevant work experience.
  • 1+ year of leadership responsibility, with demonstrated ability to lead and manage teams.

Knowledge, Skills, and Abilities:

  • Ability to apply knowledge and skills in a highly organized manner, adhering to relevant regulations, global SOPs, and client expectations.
  • Broad understanding of pharmacovigilance processes and global regulatory requirements.
  • Proficiency in Microsoft Office products and safety databases.
  • Excellent command of English with the ability to translate information when necessary.
  • Exceptional oral and written communication skills, with strong attention to detail and accuracy.
  • Strong critical thinking, problem-solving, and decision-making abilities.

Why Join Us?

At Thermo Fisher Scientific, we share a set of core values—Integrity, Intensity, Innovation, and Involvement. Be part of a global team working together to advance scientific research and improve patient outcomes worldwide.