Technical Associate II (PV Excellence)

Job Purpose:

• Provide cross-enterprise technical support within PV Excellence (PVE) and the business, as required.

• Support Global Process Owners (GPOs), Safety Process Leads (SPLs), and the business by undertaking identified operational tasks.

• Assist GPOs/SPLs in providing strategic oversight for enterprise PV processes.

• Contribute to delivering innovative, efficient, holistic, end-to-end safety processes that comply with global PV regulations and reflect enterprise business needs.

• Provide operational, technical, and maintenance support for appropriate PVE workstreams.

Key Responsibilities:

PV Excellence

• Act as Template Manager to support PV documentation in Veeva Vault (Regulatory and Clinical).

• Support interaction between PVE and third-party vendor activities for Aggregate Report management.

• Provide support for metric collection, compilation, and reporting.

• Assist with Management Monitoring activities.

• Manage access (Submission Portal, Aggregate Report shared drive, Group Management Portal, Citrix).

• Daily triage and management of group mailboxes.

• Contribute to process improvement initiatives.

• Act as Subject Matter Expert when required.

• Serve as business owner for document management systems.

• Review and maintain content on PVE-owned webpages to ensure accuracy and functionality.

• Support signal detection activities, including CVW and EMA publication reviews for signal-related data.

• Assist with Eudravigilance activities.

• Support RMP and Targeted Safety Study (TSS)/Post Approval Safety Study (PASS) activities, including RMP coordination.

• Provide support for eTMF and Medical Devices.

• Assist with Case Awareness Tool, Autolistedness profile, TOI, MedDRA, and TFQs.

• Oversee local Reference Safety Information updates and address related queries.

• Support Development Core Safety Information management.

• Assist with Safety Communications processes.

• Provide support for training, inspections, and audits.

Expected Competencies:

• Excellent organizational skills.

• Ability to work under pressure with tight deadlines while maintaining accuracy and integrity.

• Strong team player with effective communication skills (written and verbal).

• Ability to handle and escalate issues based on risk in a timely manner.

• Awareness of PV processes and global PV regulations.

• Preferred knowledge of process improvement techniques and ability to analyze performance metrics for continuous improvement.

• Preferred understanding of related disciplines (clinical, regulatory affairs, clinical statistics) relevant to aggregate report writing and clinical development.

• Ability to work independently, adapt to change, and maintain flexibility.

Education Requirements:

• Bachelor s degree in health sciences or related disciplines.

• Familiarity with medical/scientific industry desirable.

• Basic understanding of medically oriented tasks and technical support skills.

Job-Related Experience:

• 2-4 years of relevant experience.

• Fluent in English with strong communication skills.

• Excellent computer skills (Word, Excel, Internet/Intranet, document management systems).

• Familiarity with medical/scientific terminology desirable.

• Working knowledge of R\&D organization preferred.