Sr Manager Patient Safety

As the Senior Manager of Patient Safety at ADVANZ PHARMA, your primary responsibility will be to monitor and manage all aspects of updating Reference Safety Documents for all ADVANZ PHARMA products globally. You will need to maintain these documents in accordance with applicable guidelines, ensuring a global process along with region-specific processes for writing and managing reference safety documents like CCDS and SmPC. Your experience in writing reference safety documents for various types of drugs will be crucial for this role. **Key Responsibilities:** - Act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives, and upholding high-quality standards. - Manage safety-related variations and maintain product information, communicating with various stakeholders. - Revise and approve scientific documents for marketed products, such as SmPC and PIL. - Answer Health Authorities" queries in a scientific manner and support submissions with appropriate data. - Coordinate and execute global labeling compliance activities across multiple regions. - Establish successful relationships with internal and external stakeholders. - Identify gaps in reference safety documents management and lead remedial actions. - Contribute to the preparation of SOPs and WIs to ensure consistency and accuracy. - Keep abreast of changing PV requirements globally. - Embrace challenges and changes with a growth mindset approach. **Qualifications Required:** - Post-graduate qualification in Life Sciences or Pharmacy. **Additional Details:** ADVANZ PHARMA values entrepreneurship, speed, and integrity. The company fosters a collaborative environment where employees are encouraged to embrace challenges and drive personal and company growth. With a focus on diversity and inclusion, ADVANZ PHARMA actively promotes gender equality and offers opportunities for career advancement. Flexible working options, competitive salary, and benefits package are some of the perks of joining the team. If you are a highly motivated individual passionate about making a meaningful difference in patients" lives, and possess the required qualifications and experience, we invite you to apply for this exciting opportunity at ADVANZ PHARMA.,