Pharmacovigilance Quality

We are seeking a dedicated **Pharmacovigilance (PV) Quality & Compliance Expert** to join our **Global Patient Safety (GPS)** team on a 12-month minimum basis. In this pivotal role, you will ensure adherence to pharmacovigilance regulations, global guidelines, and company standards while driving compliance activities across the organization. You’ll play a key role in supporting audits and inspections, maintaining regulatory compliance, and leading process improvements to uphold the highest quality standards in patient safety.

**Key Responsibilities**:
**Regulatory & Safety Reporting**
- Ensure PV systems enable accurate reporting of adverse events and processing of safety data.
- Maintain PV system compliance by supporting development, conducting user acceptance testing, and providing actionable feedback for improvement.
- Track, analyze, and report compliance and performance metrics (KPIs) to drive process effectiveness.

**Quality Management & Compliance**
- Ensure PV processes and systems adhere to regulatory guidelines, company policies, and global standards.
- Oversee the development, maintenance, and continuous improvement of local PV processes, aligning with global GPS standards.
- Collaborate with cross-functional teams to address compliance issues and implement process enhancements.
- Monitor regulatory changes, manage compliance gaps, and implement corrective actions as required.
- Manage quality issues, including the implementation of **Corrective and Preventive Actions (CAPA)** and conducting effectiveness reviews.
- Document and oversee local compliance with PV requirements for audits and inspections, ensuring inspection readiness.

**Training & Development**
- Design and deliver pharmacovigilance training programs for internal teams and external vendors.
- Update training content to reflect new regulatory requirements and industry best practices.
- Monitor training effectiveness, collect feedback, and drive continuous improvement.

**Inspection Readiness**
- Participate in internal and external audits, ensuring accuracy and audit readiness of all documentation.

**Qualifications & Skills**:

- Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
- **5+ years of experience in pharmacovigilance, quality management, or regulatory compliance** within the pharmaceutical industry.
- Deep understanding of PV regulations (FDA, EMA, and ICH guidelines).
- Proven expertise in managing CAPAs, audits, and inspections in a global regulatory environment.
- Strong analytical skills with experience tracking and interpreting compliance metrics (KPIs).
- Excellent communication and interpersonal skills with the ability to collaborate across cross-functional teams.
- Demonstrated ability to develop and deliver effective training programs.

**Job Types**: 100%, Permanent, Fixed term
Contract length: 12 months

Work Location: Remote