Nirva Eugene

Experience

1. Associate Director, Global Marketing Program & Submission-drug Safety

   Novartis

   Oct 2014 — Present

   Monitors and leads Marketing, Market Research, Patient oriented programs (POP)and Social Media programs locally and worldwide with regards to compliance of adverse event reporting to Drug Safety. Strong knowledge of Patient Support Programs (PSP). Monitors to ensure that training is conducted for Marketing, Novartis personnel, and vendors employed by Novartis. Ensure that resources are allocated appropriately to support these functions. Represent Drug Safety in Label Advertising Claims Review meetings. Build cross-functional relationships with Marketing Team Managers and Marketing vendors to ensure Novartis Safety regulatory requirements are met. Direct and provide oversight of Marketing Program Inventory Site and site enhancements. Direct and approve corporate Social Media activities including E-Governance process, corporate Face book, YouTube, and Twitter page, etc. Liaise with affiliate Drug Safety Responsible(s) and Regional Marketing Leads to set strategy and to achieve objectives. Review, screen, provide input and approve safety related aspects of Novartis contracts with Marketing vendors. Assist the PVQA group with audits of Novartis Marketing programs and employed vendors; Support as required for regulatory inspections. Manage Drug Safety Associates/ Scientists, and other staff locally or offshore in reconciliation and other activities related to marketing program monitoring. Set up yearly objectives, conduct mid-year and annual performance reviews for the staff and assess performance issues. Set up development plans to further develop individual\'s skills and potentials. Deputize for the Head, Global Drug Safety Case Management & Global Region Head. Preparation and participation in Health Authority and Internal inspections/audits and Corrective Actions. Manage Global Submission group and ensure ICSRs are submitted on-time to Health Authorities worldwide (including FDA, EMA, MHRA). Author and implement applicable SOP’s and WI’s locally and globally.

Education

• Muhlenberg School of Nursing

  Registered Nurse, Nursing

• Rutgers University

  BA

Skills

• Regulatory Affairs
• Regulatory Requirements
• Gmp
• Clinical Trials
• Good Clinical Practice (Gcp)
• Pharmacovigilance
• Standard Operating Procedure (Sop)
• Strategy
• U.s. Food and Drug Administration (Fda)
• CRO
• Data Management
• Validation
• Fda
• Clinical Research
• Biotechnology
• 21 Cfr Part 11
• Clinical Development
• Oncology
• Quality Assurance
• Outlook
• Ctms
• Management
• Pharmaceutical Industry
• Regulatory Submissions
• Gcp
• Microsoft Word
• Sop
• Cross-Functional Team Leadership
• Leadership
• Microsoft Office