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 8+ years of total PV experience, including a minimum of 4-5 years in authoring aggregate safety reports and Risk Management Plans (RMPs) and have additional experience overseeing ICSR compliance activities at both local and global levels, then we would love 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, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore.
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.
Pharmanovias therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
Main responsibilities & duties:
- Prepare and author aggregate safety reports and regulatory documents, including PADERs, Summary Evaluation Reports (SERs), and Serious Adverse Reaction (SAR) reports
- Prepare and author Risk Management Plans (RMPs)
- Provide strategic oversight and operational management of SDEAs, including authoring, reviewing, and ensuring ongoing compliance
- Ensure compliance with ICSR submission timelines and partner obligations
- Develop and maintain internal processes to support core pharmacovigilance activities
- 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
- 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 authoring aggregrate reports, RMPs, as well as management and oversight of SDEAs and ICSR compliance activities, should have the skills and experience required for the role. We are also looking for:
- Bachelors degree in Pharmacy (Masters degree desirable)
- 8+ years of experience in pharmacovigilance with minimum 4-5 years of experience in authoring aggregate reports/RMPs is essential.
- 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
- 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.
By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
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