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.

Service Line Support

• 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.

Client Relations and Implementation

• 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.

• Medical experiences with knowledge of international drug safety regulations guidance case handling/documentation and reporting processes

• Excellent communication both verbal and written able to communicate complex and conceptual ideas effectively to all levels

• Exceptional interpersonal communication and decision-making skills with proactive and entrepreneurial spirit

• Strategic mindset with the ability to drive process improvements

• Ability to maintain professionalism focus and result-orientation under pressure and tight deadlines

• Strong organizational skills and attention to detail.

• Appreciation of working in a cross-cultural cross-functional working environment

• Advanced degree in Life Sciences Pharmacy or related field.

• 6 years in pharmacovigilance with hands-on expertise in case identification and processing and regulatory compliance in both Clinical and Post Marketing fields utilizing industry-standard safety databases and tools (e.g. Argus ARISg Veeva Vault).

• Experience with Adverse Event and Quality Complaint reporting and familiarity operating within international GxP environments and process including familiarity with validation controls and pharmacovigilance processes.

• Exposure to global regulatory compliance rules and regulations with an understanding of cross regional distinctions.

• Experience with drug or device related processes and documentation (EU GVP MDR GxP) relating to case intake and case processing from both digital and telephony avenues alongside safety reporting to regulatory bodies.

• Demonstrated success preparing for audits and health authority inspections with strong CAPA management.

• Recognition of process oriented and documentation driven activities critical to any Pharmacovigilance related activities such as SOPs Training Programs and Quality Assurance Frameworks.

• Knowledge of HIPAA and EU privacy laws including GDPR

Desired Skills and Experience

Familiarity operating within GxP environments including familiarity with validation controls and pharmacovigilance processes

Experience working at global CRO or international pharmacovigilance department is a plus

Proven track record leading literature surveillance teams or projects for global pharma clients.

PMP/Project Management certification and Six Sigma/Lean process improvement credentials.

Forward thinking approach to technology AI and innovation within the Pharmacovigilance Industry