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Pharmacovigilance Manager

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Pharmacovigilance Manager

Remote

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Join Thermo Fisher Scientific Inc. as a Pharmacovigilance Manager and be at the forefront of ensuring patient safety in an outstandingly collaborative and innovative environment. This is an outstanding opportunity to contribute to world-class research initiatives and work with a team dedicated to making a global impact.

Job Responsibilities

Discover Impactful Work:

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team

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A day in the Life:

  • Monitors, evaluates, and proposes mitigation strategies surrounding risk to PV project deliverables and finances.
  • Serves as Key point of contact for client.
  • Accountable for project financial stewardship and participates decision-making for options with the client for various increases in scope of work to drive healthy gross profit and revenue margins.
  • Drives timelines and tasks/deliverables for safety reporting PV functions
  • Prepares and leads operational/tactical/governance calls with client(s).
  • Coordinates and leads preparation and attendance in client audits/inspections.
  • Maintains effective communication and coordination with other functional groups concerning project topics/issues.
  • Coordinates generation of project metrics (e.g., key performance indicators, volumes, etc.).
  • Maintains budget/financial oversight of assigned project(s), working with applicable teams for contractual activities (i.e., change notification forms, contract modifications, renewals, etc.) for all PV services.
  • Responsible for presenting on internal financial and project review meetings.
  • Accountable for collaboration with all PV functions to ensure critical metrics meet agreed targets.
  • Leads departmental initiatives.

Education

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
  • 1+ year of leadership responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to relevant legislation/regulations/guidance, global SOPs and client expectations
  • Broad understanding of PV along with working knowledge of the global regulatory requirements and the importance of procedural/process compliance
  • Proficient in Microsoft Office products and safety databases
  • Good command of English and ability to translate information into local language where required
  • Excellent oral and written communication skills
  • Strong attention to detail and accuracy
  • Strong critical thinking, problem solving and decision-making skills

Job ID: ThermoFisher-R-01283890-1
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program