Pharmacovigilance Operations Lead

Given the great interest in Pharmacovigilance Services at TransPerfect, the role will involve subject matter expertise in Literature Monitoring and further development of AI and automation solutions across wide ranging PV activities. Key responsibilities will involve bridging client relations, technology teams and streamlining project implementation through Subject Matter Expertise.

• Oversee daily surveillance and systematic triage of biomedical literature for safety signal detection

• Lead and refine global literature monitoring operations aligned with health authority expectations (FDA, EMA, MHRA, PMDA, etc.).

• Prepare for and participate in regulatory audits and inspections, implementing CAPAs and continuous improvement measures as required.

• Establish, review, and update SOPs, workflows, to maintain regulatory compliance and inspection readiness.

• Serve as internal Subject Matter Expert (SME), providing guidance on complex cases, compliance, and timely audit/inspection support.

• Mentor and train internal staff, ensuring continuous knowledge transfer and upskilling to bridge any domain or compliance gaps.

• Oversee an internal team of Safety Case Reviewers, ensuring accuracy and timely review and triage of cases.

• Contribute to educational and training materials/sessions to strengthened GxP knowledge and process understanding.

• Responsible for implementing business continuity plan, management and documentation of incidents / service interruptions.

• Support business development with technical input on client proposals and presentations, reinforcing organizational expertise and credibility.

• Work alongside Production, Clients and relevant internal Technology Teams to onboard and regularly maintain scientifically robust literature search strategies (e.g. keyword selection, syndication criteria, drug synonym mapping, MedDRA term identification) to ensure comprehensive capture of relevant safety information.

• Partner with external stakeholders, vendors, and cross-functional teams to align literature monitoring strategies and reporting requirements to meet client needs.

• Maintain, document, and refine criteria ensuring that client safety requirements and expectations are clear with consistent, and timely communication to the Safety Review Team

• Promote a forward-looking process improvement culture, integrating technology and innovation (e.g., RPA, NLP, AI-driven workflows), maximizing operational efficiency and transparency and supporting demos.