Sr Safety Reporting Specialist

Job Description

• Maintains current knowledge and actively monitors and researches the Regulatory PV and safety reporting landscape commensuration with their Regulatory Intelligence country-specific role and assignment of specific topics.
• Evaluates regulatory changes, proactively assess the impact, and takes all the necessary actions in a timely manner resulting due to the update. (such as decimating the updates to teams, updating specific systems concerned etc.)
• Helps fellow team members and other colleagues with enquiries related to their country specific regulatory intelligence.
• Liaison with internal departments regarding regulatory changes and impact on business and in specific PV department.
• Communicates with regulatory authorities, ethics committees and third parties as required for evaluating regulatory changes.
• Receives, prepares, and submits safety reports to applicable parties, ensuring 
• compliances at all stages. 
• Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress.
• Exercises independent judgement to troubleshoot, resolves project issues and identifies areas for improvement. 
• Leads and monitors large and complex projects effectively to ensure that all aspects of the project are completed successfully and on time.
•  Attends and presents at various meetings as required. 
• Facilitates and advises on company, client and regulatory audits where required. 
• Provides training and support to lower-level team members, mentors new starters, provides input on individual performance and shares ideas and suggestions with team members. 
• Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.