Senior Manager, Pharmacovigilance

Mumbai, India (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed and detail-oriented pharmacovigilance specialist, with global experience in the oversight and maintenance of Pharmacovigilance System Master Files, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future – in our products, our brands and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Spain, Germany, China, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As Senior Manager, Pharmacovigilance, you will be responsible for the authorship and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), and for overseeing all activities related to the benefit-risk evaluation of drugs, to ensure a favourable benefit-risk profile is maintained.

In this position you will report to and will work closely with the Associate Director, Pharmacovigilance, and play a key role in shaping and guiding the direction of the department to ensure both regulatory compliance and alignment with organisational goals.

You will possess extensive knowledge of EU-GVP, US FDA, and other global and local pharmacovigilance regulations. Strong communication skills are essential, with the ability to engage effectively across internal teams and with external partners.

The department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment. 

Main responsibilities & duties:

• Develop and maintain in-house processes to support key internal pharmacovigilance (PV) activities
• Author and/or review the Pharmacovigilance System Master File (PSMF)
• Prepare and review aggregate safety reports and Risk Management Plans (RMPs)
• Lead and support the hosting of PV audits and regulatory inspections
• Respond to queries from regulatory authorities related to PV products
• Contribute to product labelling activities in alignment with safety data
• Support the management of audits, inspections, and associated CAPAs related to PV operations
• Assess and implement relevant regulatory intelligence updates impacting PV functions
• Prepare and maintain the aggregate reporting schedule, including review of the EURD list
• Support pharmacovigilance risk assessments and due diligence activities, as required
• Monitor PV compliance across key workstreams and ensure corrective measures are implemented where necessary
• Support implementation of Risk Management plan and perform effectiveness check
• Develop, track, and report key performance indicators (KPIs) to senior leadership
• Collaborate with cross-functional leaders and senior management to provide PV oversight and contribute to broader organisational objectives

About you:

Candidates with progressive pharmacovigilance experience, specifically in benefit-risk evaluation and management, as well as oversight and maintenance of the Pharmacovigilance System Master File (PSMF), should have the skills and experience required for the role. We are also looking for:

• Master’s degree in Pharmacy or Bachelor's degree in Medicine (Allopathy or Allied Sciences)
• 12+ years of experience in pharmacovigilance
• Experience in working with core pharmaceutical companies desirable
• Strong knowledge of PV regulations at local and global level
• Experience in management of SDEAs
• Experience authoring and reviewing benefit risk evaluation documents (PSUR, PBRER, RMP)
• Organised and inquisitive, with the ability to perceive, understand and interpret facts quickly and precisely
• Solid time management skills, the ability to multitask and see the big picture
• Strong technical skills and a problem-solver
• Adaptability and resilience

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.