Jennany Mahendran

Senior Affiliate Pharmacovigilance Partner Compliance Specialist @AbbVie

Country Lead for Germany & Austria outsourced PV Activities-Subject Matter Expert for Submissions and Literature Screening-Training and onboarding facilitator for the team.My Day to Day Activities include- Establish standards and oversee the monitoring of outsourced processes, investigate and lead the follow-up of discrepancies- Lead the monitoring of supplier performance via SLAs and other metrics, prepare routine and ad hoc reports, lead the investigation of trends, and escalate issues as appropriate- Present results of quality control and trend analysis to senior, cross-functional AbbVie stakeholders- Support the establishment of AbbVie quality management processes for external suppliers of affiliate Pharmacovigilance services that meet applicable PPS, RDQA, and affiliate standards and ensure reproducible, controlled, and timely delivery of high quality outputs- Collaborate with suppliers and internal partners to implement vendor quality management processes which integrate with supplier and AbbVie processes wherever possible. Support the use of risk-proportionate approaches for in-line and retrospective evaluations- Support development of materials and deliver training sessions (through multiple modalities) in conjunction with supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed- Lead issue investigation (eg CAPAs), coordinating between AbbVie and supplier systems. Support the communication and collaborate across internal and partner stakeholders for prioritization of issues, as well as timely, effective, and permanent remediation actions- Proactively lead the identification of areas of process and technical improvement and lead the implementation of changes- Responsible as a member of the Vendor Management Team for driving compliance and business excellence for all of outsourced affiliate PV activities