Senior Manager, Patient Safety

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:   

• Draft/Review of Periodic Safety Update Reports and Periodic Adverse Drug Experience Reports from a medical standpoint
• To prepare Signal reports (including DSR, DEP, SAR as applicable) and managing the compliance and quality of signal detection.
• Medical writing to support product safety reviews and clinical evaluations

• Support if required to draft/review ad hoc safety reports like RMP, CES, HA response in stipulated time frame.
• Contribute towards continued improvement of safety systems and processes
• Oversight of safety related variations and maintenance of product information
• Keep abreast of changing PV requirements across Europe and Rest of World
• Represent the company during Scientific meetings and Audits and Inspections
• Compliance with GPvP requirements, demonstrated through audits and inspections.
• Support to the business and provision of documentation within agreed timeframes
• Successful relationships with all external partners
• Address internal and external inspection findings
• Ensure all documentation is structured and maintained as required
• Ensure PV systems are in line with industry standards
• Interaction with Regulators, patients and prescribers from a safety perspective if required.

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: 

• MD/MBBS

Knowledge, Skills & Experience:

• Must have Experience in Signal Detection
• Aggregate Reports
• Team Handling experience is  preferred

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.