Specialist - Patient Safety

Location: Andheri, Mumbai.

(Hybrid working)

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve 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 complement 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 role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers – both internal and external - and generating and communicating relevant, meaningful, and impactful data.

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.
• 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: 

• Tertiary qualification in any discipline within Life sciences or Pharmacy.
• Post-graduate qualification (e.g. Masters) in an industry relevant field.

Knowledge, Skills & Experience:

• Must have significant experience in Drug safety or Pharmacovigilance in a pharmaceutical company.
• Proven ability to analyze scientific data.
• Medical Writing experience (e.g. PSURs, Safety variations, RMPs, Clinical and Non-Clinical components of product dossiers).
• Experience in Compliance tracking (e.g. PSMF, safety databases) and Pharmacovigilance Audits.
• 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.