Pharmacovigilance duties
- Supervise third party in charge of end-to-end adverse events case processing
- Submission of product specific data and benefit risk assessment (e.g., PSUR, DSUR, RMPs)
- Support regulatory affairs with PV related submissions
- Ensure appropriate dissemination and tracking of DHCP and Dear Investigators letters
- Supported inspections, visits and audits as well as CAPAs management
- Participation in local and external pharmacovigilance activities and support area lead with specific PV tasks assigned
- Chair cross-functional drug safety committee and be responsible for communication with external parties related to clinical safety monitoring such as Data Monitoring Committees & Risk Forums
- Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
- Reviewed, compiled and analyzed data for safety database management.
- Trained staff and updated training documents to meet regulations and standards.
- Prepared variety of different written communications, reports and documents.
Digital Medical Comms duties
- Supported medical affairs with ideas and innovative processes to drive change in the department
- Participated in innovation meetings and seminars and implement ideas to improve existing processes
- Supported in hiring external experts and key opinion leaders who act as speakers in congresses, meetings, and events.
- Deveop, design, and approval process of non-promotional materials in Content Lab (Veeva).
- Assisted in managing corporate social media channels.
- Drafted weekly e-newsletters and set up campaigns in MailChimp.
- Contributed to mock-ups, email campaigns and social media content.
- Worked with various vendors and suppliers for service and equipment as needed
- Organized logistics and materials for internal and external meetings, arranged spaces and took detailed notes for later dissemination to key stakeholders.
- Supervised onsite team of caterers, audio-visual technicians and facility management team.
- Managed administrative logistics of events planning, event booking and event promotions.
- Managed the creation of purchase orders through Ariba Guided Buying as well as coding invoices and obtaining approvals for payment/processing as well as troubleshooting billing issues
- Collaborated closely with Business Operations Specialists to ensure local business process documentation is consistently in an audit-ready state
- Managed calendar for leadership team members
- Supported travel logistics for leadership team members in compliance with GSKs T&E policies
- Assisted internal staff with clerical and administrative needs to maximize efficiency and team productivity.
- Acted as Ariba (contract management system) Super User and support teams accordingly
- Prepared, submitted, and tracked expense reports for leadership team members in accordance with T&E policy
- Efficiently resolved day-to-day business operations issues