Job Description:
Responsible for strategic oversight of safety related labeling variations impacting regulated pharmaceutical drug products while ensuring regulatory compliance, patient safety, and consistent communication of product information across global markets.
Essential Duties and Responsibilities :
- This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
- Key Interface between Pharmacovigilance (PV), Regulatory Affairs Labeling Team and Global Labeling Operations
- Ownership and Establishment of Safety Labeling Processes for GRA including but not limited to:
- CCDS and associated Safety Variations
- Generic Labeling and Monitoring of Innovator Labels
- PRAC and MOH triggers
- Oversee generic labeling surveillance and innovator-label monitoring
- Oversee PRAC recommendations
- Lead continuous improvement and KPI reporting including but not limited to CCDS metrics including coordination of Client's
- Safety labeling governance and compliance oversight of safety related labeling changes across global markets (i.e., escalate risks associated with overdue safety variations)
- Develop Training Materials for improved safety variation submission process and related system changes
- System Owner for Fluxguard and CCDS/Safety Labeling Tracking
- Support PV and RA inspections as it relates to safety labeling
- Represent GRA function on PV Safety Signal Meeting
Qualifications :
- Scientific knowledge
- Ability to multitask and prioritize
- Ability to work effectively in multinational/multicultural environment
- Sound basis of Regulatory knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Strong interpersonal, communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Technical and management skills
- Ability to lead and coach others
- Ability to independently identify compliance risks and escalate when necessary
Education and/or Experience:
- Bachelor's degree or country equivalent in a scientific discipline
- Masters and/or PhD will be an advantage.
- Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.