The Senior Manager of Patient Safety will be accountable for monitoring and managing all aspects of updating Reference Safety Documents like CCDS, SmPC, PI, PIL, datasheets, and product monographs for all ADVANZ PHARMA products across the Globe. The documents shall be maintained in line with applicable guidelines. The role must ensure that it has a global process along with region-specific processes in writing and managing the global reference safety document, like CCDS, or regional reference safety documents like SmPC. Role must be experienced in writing reference safety documents for Innovator drugs, well-established branded drugs, branded generics, generics & biosimilars.
- Act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives, and upholding high-quality standards.
- Responsible for safety-related variations and maintenance of product information, including communication to various stakeholders.
- Revise and/or supervise revision and approve the scientific documents for the products marketed by the Company, such as summary product characteristics (SmPC), Patient Information Leaflet (PIL), etc.
- Answer queries from the Health Authorities related to products marketed by the Company in a scientific manner and support the necessary submissions with appropriate data.
- Responsible for planning, coordinating, and executing global labeling compliance activities to meet regulatory requirements across multiple regions. Ensure that labeling processes, documentation, and systems remain accurate and inspection ready.
- Successful relationships with all external and internal stakeholders.
- Seek and deliver operational efficiencies across the Patient Safety, Clinical development, Medical Affairs, Regulatory Affairs, Artwork, and Quality team.
- Ensure all documentation is structured and maintained as required through the implementation of Good Documentation Practices (GDP).
- Actively coordinate with all the internal and external stakeholders to ensure Pharmacovigilance and Regulatory compliance in line with the Pharmacovigilance Safety Master File (PSMF).
- Identify gaps and areas for improvement in reference safety documents management and lead remedial actions and initiatives.
- Participate in the preparation of drafts for Standard Operating Procedures (SOP) and Work Instructions (WI) to ensure consistency, allocation of responsibilities, accuracy, timeliness, and implementation.
- Keeping abreast of changing PV requirements globally, with a specific focus on Rest of World territories.
- Thrive in an entrepreneurial environment and take accountability for results.
- Embrace challenge and change, applying a growth mindset approach.
- Have a bias for action and fast decision making.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation.
- Contribute to making ADVANZ PHARMA a desired place to work.
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives.
For this role, you will also have the following: Qualifications: Post-graduate qualification in any discipline within Life sciences or Pharmacy.
Knowledge, Skills & Experience:
- Must have significant experience in experience in Patient Safety with maximum experience in monitoring and managing all aspects of updating Reference Safety Documents, such as Core Data Sheets (CCDS), Summary of Product Characteristics (SmPC), Product Information (PI), Patient Information Leaflets (PIL), datasheets.
- Should have exp of innovator molecules or biosimilars.
- Thorough knowledge of end-to-end labelling, Labelling Management Systems (e.g., Veeva Vault) and related document management tools.
- Has knowledge of QRD Templates from EU.
- Ability to effectively demonstrate leadership in a team environment, which requires negotiation, persuasion, collaboration, and analytical judgment.
- Self-starter, strategic mindset, results-driven, stakeholder-centric focus, team player, and accountability.
- Open and adaptable to challenging environments.
