Compliance Manager, Pharmacovigilance and Medical - Milano, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific

Azienda verificata

Milano, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

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 mínimal 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 coauditor 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.
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.