Pharmanovia
Website:
pharmanovia.com
Job details:
Mumbai, India -Based – (Hybrid role: 3 days office, 2 days home per week)
About The Company
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 by revitalising niche, trusted medicines. Since 2013, we have grown consistently, supported by a diverse global team of over 300 employees across 29 nationalities. Our therapeutic focus includes Cardiovascular, Oncology, Endocrinology and Neurology, and we partner with leading pharma companies to maximise the lifecycle value of established medicines.
About The Role
We are seeking a Senior Manager – Pharmacovigilance to lead key activities related to benefit-risk evaluation and global safety oversight across our product portfolio. This is a high-impact role working closely with senior leadership to ensure regulatory compliance, robust pharmacovigilance systems, and proactive safety management across global markets.
Responsibilities
- Lead the benefit-risk evaluation strategy, including preparation and review of PSURs, PBRERs, RMPs and signal detection outputs
- Oversee and drive signal detection, evaluation and risk management activities, ensuring a favourable product safety profile
- Author and maintain the Pharmacovigilance System Master File (PSMF) and ensure inspection readiness
- Establish and manage pharmacovigilance vendor oversight frameworks, including onboarding, performance monitoring and compliance
- Lead and support regulatory inspections and PV audits, ensuring audit readiness and CAPA management
- Develop and maintain the aggregate reporting schedule, including the EURD list management
- Respond to health authority queries and ensure timely, accurate regulatory submissions
- Monitor PV compliance across global activities and drive corrective and preventive actions (CAPAs)
- Support labelling updates based on emerging safety data and regulatory requirements
- Provide PV input into due diligence, risk assessments and product lifecycle decisions
- Track and report KPIs and performance metrics to senior leadership
- Collaborate cross-functionally with Medical, Regulatory and Quality teams to ensure an aligned safety strategy
- Stay current with global regulatory intelligence (EU-GVP, FDA and local requirements) and implement necessary changes
Qualifications
- 12+ years’ experience in pharmacovigilance, with a strong focus on benefit-risk evaluation and safety management
- Proven expertise in authoring and reviewing PSURs, PBRERs, RMPs and signal detection documentation
- Strong knowledge of global PV regulations (EU-GVP, FDA and local requirements)
- Experience authoring and maintaining PSMF
- Demonstrated experience in PV audits, inspections and CAPA management
- Experience managing PV vendors and third-party relationships
- Strong understanding of aggregate reporting and safety data analysis
- Master’s degree in Pharmacy or Bachelor’s degree in Medicine (or equivalent scientific discipline)
Required Skills
- Strong analytical and problem-solving skills with high attention to detail
- Excellent communication and stakeholder engagement skills
- Ability to influence and collaborate with senior stakeholders
- Proactive, resilient and solutions-oriented mindset
- Strong organisational and prioritisation capabilities in a fast-paced environment
Preferred Skills
- Play a key role in shaping global pharmacovigilance strategy
- Work in a high-impact, senior position with strong visibility
- Join a fast-growing, innovative global pharmaceutical company
Pay Range And Compensation Package
We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.
Equal Opportunity Statement
Pharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Pharmanovia will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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