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Thermo Fisher Scientific

Compliance Manager, Pharmacovigilance and Medical Communications

2 weeks agoRemote

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

We are currently recruiting for a QA Auditor III/Compliance Manager to join our internal Process Audit team. This role will initially be focused on supporting our Pharmacovigilance and Medical Communications audit programme but will have scope to also work on our teams GCP audits too. As Compliance Manager, your responsibilities are to assess company activities to assure PPD meets regulatory, company and client expectations and determine whether operations are conducted in compliance with requirements. You will join a team of experienced quality professionals and will lead assigned Pharmacovigilance and Medical Communications audits and work with minimal supervision.

Essential Functions:

  • Plans and leads a variety of internal Pharmacovigilance audits and supports regulatory inspections as requested by senior management
  • Participate in other GxP audits
  • May lead as directed, site audits, facility, vendor and/or sub- contractor audits
  • Provides Pharmacovigilance and GxP consultation and support to PPD project teams and external clients, leads process audits and may participate as a co-auditor in more complex system audit
  • Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
  • Provides mentorship and guidance to junior auditors.

The successful candidate will have the following combination of education, experience, knowledge and skills:

  • Bachelor's degree in a life science area
  • Experience of Pharmacovigilance and Medical Communications operations in a pharmaceutical or CRO environment
  • Significant Pharmacovigilance auditing experience
  • Experience leading audits and teams of auditors is an advantage
  • PV Auditor training (e.g. RQA/Practical PV auditing) and GCP audit experience is desirable
  • Thorough knowledge and understanding of Global Pharmacovigilance regulations and Guidelines
  • Negotiation and conflict management skills
  • Proven flexibility and ability to adapt quickly to shifting priorities and workload

Our 4i Values:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Job ID: ThermoFisher-R-01217382_1002-1
Employment Type: Full Time