Gms Compliance and Regional Pv Specialist

5 months ago

Chalfont Saint Giles, United Kingdom GE Healthcare Full time

**Job Description Summary**: GE HealthCare’s Global Medical Services (GMS) organization includes the Global Pharmacovigilance (PV) and Medical Affairs groups in the Pharmaceutical Diagnostics (PDx) business. As a GMS Compliance and Regional PV Specialist, you will be part of the GMS Organization reporting into the Compliance and Training Function. You will actively contribute to the safety of our products on both a regional and global level.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

**Responsabilities (but are not limited to)**:

- Support local PV systems in several countries in collaboration with Global PV and EUQPPV, as needed
- Act as deputy local PV contact person for local PV units in Europe and UK as needed. In that role, assist with end-to-end local Adverse Events management, in compliance with national legislation and internal procedures
- Support the maintenance of a training system for PV related tasks; this may include regional, local and global PV training
- Assist with maintaining the database for Local/Regional PV partners, including contact information, agreement status, local regulatory reporting requirements and training records. Support the onboarding and training activities for local PV partners.
- Perform reconciliation activities with local partners and stakeholders to ensure compliance with PV regulatory requirements.
- Assist with GMS Compliance and Training governance activities such as:

- Preparation of metrics and reporting to GMS
- Quality Control assessments of reports entered in the safety database
- Audit and inspection readiness and support during audits and inspections
- Identify non-compliance and contribute to the investigation and development of corrective and preventive action plans
- Actively participate in departmental and various cross-functional project teams.
- Adhere to PV responsibilities outlined in third-party agreements (distributor, contractor, collaborative partners). Track safety data exchange information to ensure compliance with SDEA

**Qualifications**:

- Academic degree in sciences, nursing, pharmacy, or medical degree
- At least 3 years of experience in Pharmacovigilance, Quality and or Regulatory activities within Pharma/Life Sciences Industry
- Strong knowledge of good vigilance practices (GvP)
- Self-motivated with ability to prioritize, schedule, and organize daily activities
- Excellent communication skills: ability to communicate across organization levels and to connect with different audiences in a multicultural environment
- Fluent English (written and spoken); proficient knowledge of other languages will be an asset
- Ability to set priorities and pivot as required.
- Reliability and flexibility and willingness to travel occasionally

**Inclusion and Diversity**:
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

**Behaviours**:
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

**Total Rewards**:
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

**Additional Information**:
**Relocation Assistance Provided**:No

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