Senior Manager, Patient Safety (Andheri (East), IN, Mumbai 400) chez ADVANZ PHARMA

Location: Andheri, Mumbai.

(Hybrid working)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose of improving patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network, complements our global operations.

ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

About the Role

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.

What You’ll Do:  

• 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.

About You

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.

• Ability to work with different Global culture and different time zones.
• Excellent attention to detail and innovative solution finding ability.
• Excellent communication skills. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others.
• A positive and ‘can-do’ approach, biased towards finding solutions and embracing change.
• Inspired by our values of entrepreneurship, speed and integrity.
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows.
• Work collaboratively across all business functions with an open, honest, and respectful cooperation.
• Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment.  We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities, and make things happen.

But there’s more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women’s Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now! *

*Please include a CV and Cover letter.