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Principal Safety Reporting Specialist
Pharmaceutical Product Development (PPD)
Taguig City, Philippines
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 judgment 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.
Job posted: 2024-05-02