Date 27 Nov 2025 Location Andheri East IN Mumbai 400 Company AdvanzPharma 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 market-competitive salary and benefits package To join us on our exciting journey Apply now Please include a CV and Cover letter