Role Summary
Team Leader - Pharmacovigilance. The Team Lead β PV case processing is responsible for managing the Case Processing Team within Elanco Innovation and Alliance Center for India (EIACI). The role includes coordination, collaboration, and leadership for GPV activities, as well as oversight and guidelines for adverse event and product complaint case processing/management. The team leader supports and drives business and operational projects important to the overall GPV organization.
Responsibilities
- Leadership and People Management of the Case Processing Team
- Lead, motivate and work with the Case Processing team members to provide them with appropriate objectives/personal development plans/career opportunities
- Support recruitment process to select appropriate candidates to meet business needs
- Liaise with colleagues in GPV to ensure a coordinated approach and consistent case processing standards throughout the GPV organization
- Active engagement in the GPV team meetings
- Global Product Expertise and Accountability
- Quality and Compliance Management
- Ensure quality and consistency of pharmacovigilance case data
- Ensure timely processing of cases to enable regulatory compliance with global adverse event reporting requirements
- Ensure staff are appropriately qualified and trained for tasks that they are required to perform
- Monitor quality, compliance and productivity metrics for personnel and rectify any shortfalls with assistance of GPV support function
- Ensure adverse event data is available for thorough analysis, proper monitoring, and safety evaluation for all Elanco products
- Lead or contribute to business process improvement initiatives
- Promote quality improvements and recommendation of process changes as needed
- Ensure improvement in productivity and quality of the work by the team in collaboration with other GPV leaders
- Build working relationships with management in relevant areas
- Actively seek out information on the needs of internal and external customers
- Identify issues, propose solutions and communicate them to appropriate governance
- Build working relationships with pharmacovigilance and other regulatory personnel, call center personnel and quality personnel in affiliate offices to broaden understanding of clinical development and commercialization
Qualifications
- Required: Veterinarian (equivalent to US DVM) or Bachelorβs degree in Life Sciences with a minimum of 10 years total pharmacovigilance experience (at least 2 years in animal health pharmacovigilance)
- Preferred: Minimum of 2 years team management/leadership experience
- Preferred: Ability to build technical expertise within the Case Processing team through recruitment, development, retention, and management of staff and to manage resources to meet business objectives
- Preferred: Adherence to quality systems and procedures, and use of sound pharmacovigilance and technical knowledge to deliver quality data
Education
- Related degree as specified above in Qualifications
Additional Requirements
- Travel: 0%
- Location: IN, Bangalore - Hybrid Work Environment