Job Purpose 

With strong entrepreneurial attitude and moderate levels of supervision, the incumbent is responsible for providing quality and compliance oversight to the Europe region and help ensure that the pharmacovigilance, clinical development, medical affairs, market consumer research and applicable regulatory activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and Novartis established quality standards and practices in an efficient and expeditious manner.

Major Accountabilities

1.

 Plans and conducts PVCQA audits independently or as a team in a lead or support role as required.

Communicates audit findings both verbally and in writing utilizes approved electronic audit systems proficiently, evaluates and follows up on the appropriateness and completeness of corrective action plans until closure. PVCQA audits are either routine or for-cause/directed and can include clinical investigator sites, clinical and/or pharmacovigilance systems and/or processes, regulatory submission related documents, third party vendors, [e.g., CROs, central laboratories, phase I facilities], country affiliate organizations, central sites or global functions, license partners

2. Supports clinical and/or pharmacovigilance teams, leads quality projects or initiatives as required cross-functionally and/or across business units; as a PVCQA subject matter expert supporting the Europe region, provides compliance/quality/QA related guidance and oversight.

3. Actively participates in the SOP and local regulatory submission document reviews and approval processes.

4. Supports, manages, leads and/or hosts regulatory inspectional activities globally particularly countries in the Europe, before, during and post inspections.

5. Contributes to determination of audit targets, audits scheduling and planning, and refining PVCQA operations, processes, written procedures and tools as needed.

6. Proactively develops and/or provides GCP and PV QA/compliance/quality related training/education to targeted functional units within the regional organization as needed

7. Proactively initiates or participates in regional quality initiatives, innovation and continuous improvement processes where PVGCP expertise is required; shares results and with global functions [e.g., CDMA, DSP, Marketing]

8. Develops network of communications with regional and country stakeholders and functional leaders;shares and collaborates relevant information, PVGCP-related compliance directives or guidances, issues and concerns

9. In collaboration with regional QA representatives, provides advice and serves as liaison/POC for country-related application of quality systems and standards [e.g., QMs, global quality plan, quality ssessment]

10. Facilitates GPvP and GCP -related issue resolution process, recommending strategic steps to resolve or mitigate with short and long term corrective and preventative actions

11. Oversees compliance of regional and global patient support programs with Novartis quality and reguatory standards

12. Executes other assigned tasks to achieve PVCQA project-related quality and change objectives

Background

Bachelor’s degree is required. Advanced degree is desirable.

  Ø 8+ years of pharmaceutical industry experience in quality assurance, pharmacovigilance,clinical research and drug development, regulatory affairs or regulatory compliance, with 3+ years GCP/PV auditing/compliance or equivalent GxP experience

 Ø Working knowledge of applicable PV and/or GLP, GCP regulations and guidelines

 Ø Working experience within international & multidisciplinary environments

 Ø IT systems literate (MS Word, Excel, & Power Point) and familiarity with required audit tracking systems