Pharmanovia is a fast-growing global pharmaceutical company specializing in revitalizing niche, trusted medicines to improve patient health worldwide. With a portfolio of over 20 brands across 160+ markets, we focus on Cardiovascular, Oncology, Endocrinology, and Neurology therapies.
Why Join Pharmanovia?
- Innovative Culture: Entrepreneurial spirit with a commitment to quality.
- Global Impact: Work with a diverse team of 300+ employees across 12+ countries.
- Career Growth: Continuous learning and leadership opportunities.
- Work-Life Balance: Hybrid work model and employee well-being programs.
1. Associate Manager, Pharmacovigilance
Job Description:
The Associate Manager, Pharmacovigilance will oversee Safety Data Exchange Agreements (SDEAs) and Individual Case Safety Reports (ICSRs) compliance. This role ensures adherence to global pharmacovigilance regulations (EU-GVP, US FDA) and supports audits, regulatory submissions, and risk assessments.
Key Responsibilities:
✔ Manage SDEAs (drafting, reviewing, compliance monitoring).
✔ Oversee ICSR vendor management (sample reviews, dashboards, compliance tracking).
✔ Ensure timely ICSR submissions per regulatory requirements.
✔ Support pharmacovigilance audits & inspections.
✔ Contribute to aggregate reports (PADERs, SERs, SARs).
✔ Monitor regulatory updates and implement necessary changes.
Qualifications:
- Bachelor’s/Master’s in Pharmacy.
- 8+ years in pharmacovigilance, preferably in pharma.
- Strong knowledge of global PV regulations.
- Experience in SDEA management & ICSR compliance.
- Organized, detail-oriented, and adaptable.
2. Senior Manager, Pharmacovigilance
Job Description:
The Senior Manager, Pharmacovigilance will lead Pharmacovigilance System Master File (PSMF) maintenance and benefit-risk evaluations for drugs. This role ensures compliance with global PV regulations and supports regulatory inspections.
Key Responsibilities:
✔ Author and maintain PSMF and Risk Management Plans (RMPs).
✔ Prepare aggregate reports (PSURs, PBRERs).
✔ Lead PV audits & regulatory inspections.
✔ Support labeling updates based on safety data.
✔ Monitor PV compliance & implement CAPAs.
✔ Conduct pharmacovigilance due diligence for new products.
Qualifications:
- Master’s in Pharmacy or Bachelor’s in Medicine.
- 12+ years in pharmacovigilance (pharma industry preferred).
- Expertise in PSMF, PSURs, RMPs.
- Strong regulatory knowledge (EU-GVP, US FDA).
- Analytical, problem-solving, and leadership skills.
How to Apply?
Application Link Senior Manager, Pharmacovigilance
Application Link Associate Manager, Pharmacovigilance
