Associate 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 professional, with experience of managing SDEAs and oversight of ICSR compliance activities, at both a local and a global level, 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 Associate Manager, Pharmacovigilance, you will be responsible for the management of Safety Data Exchange Agreements (SDEAs) and for overseeing the quality review and monitoring of Individual Case Safety Reports (ICSRs).

In this position you will report to and work closely with the Associate Director, Pharmacovigilance, and play a key role in ensuring the department maintains compliance with both regulatory requirements and internal procedural standards.

You will have a strong understanding of EU-GVP, US FDA, and other global and local pharmacovigilance regulations. Excellent communication skills are essential, with the ability to collaborate effectively across internal teams and with external stakeholders.

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:

• Provide strategic oversight and operational management of SDEAs, including authoring, reviewing, and ensuring ongoing compliance
• Oversee ICSR vendor management, including sample review of ICSRs, dashboard creation, and compliance monitoring
• Develop and maintain internal processes to support core pharmacovigilance activities
• Ensure compliance with ICSR submission timelines and partner obligations
• Support and participate in pharmacovigilance audits and regulatory inspections
• Contribute to product labelling activities based on safety data and evolving benefit-risk profiles
• Monitor and assess regulatory intelligence updates and implement necessary changes to PV systems and practices
• Support the preparation of regulatory documents, including PADERs, Summary Evaluation Reports (SERs), and Serious Adverse Reaction (SAR) reports
• Assist with pharmacovigilance risk assessments and due diligence activities for new products or partnerships
• Develop, track, and report key performance indicators (KPIs) to senior leadership for informed decision-making
• Collaborate cross-functionally with internal leadership teams to ensure PV oversight aligns with broader business goals

About you:

Candidates with progressive pharmacovigilance experience, specifically in management and oversight of SDEAs and ICSR compliance activities, should have the skills and experience required for the role. We are also looking for:

• Bachelor's degree in Pharmacy (Master’s degree desirable)
• 8+ 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 in ICSR review and compliance monitoring
• Experience authoring aggregate reports (PADERs, SAR, SER, etc.)
• Organised and inquisitive, with problem solving skills
• Solid time management skills, the ability to multitask and see the big picture
• Strong technical skills
• 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.