PrimeVigilance, a global leader in Pharmacovigilance and drug safety operations, is hiring for two major positions in India: Senior Benefit-Risk Associate (Pune) and Senior Medical Writer (Bengaluru/Remote).
These roles offer excellent growth opportunities for professionals in pharmacovigilance, medical writing, and drug safety looking to work with international life-science teams.
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1. Senior Benefit-Risk Associate – Pune
Job Overview
PrimeVigilance is seeking an experienced Senior Benefit-Risk Associate with strong expertise in signal detection and signal management tools. The role involves analyzing safety signals, drafting high-quality detection reports, evaluating risk-benefit data, and ensuring regulatory compliance.
Key Responsibilities
- Participate in end-to-end signal detection activities, including setup
- Review line listings for signal detection reporting
- Draft, edit, and quality-check complex signal detection reports
- Evaluate and categorize potential safety signals
- Recommend appropriate regulatory actions upon identifying signals
- Support communication with regulatory authorities
- Maintain PV documentation and tracking systems
- Collaborate with cross-functional departments to ensure procedural compliance
Qualifications
- Life Science/Biomedical background (Pharmacy preferred)
- Prior experience in pharmacovigilance signal detection
- Strong understanding of signal management systems/tools
- Excellent analytical ability with attention to detail
- Strong communication skills; English proficiency (B2+)
- Motivated individuals passionate about patient safety
Benefits
- Global exposure across EU, US, and APAC teams
- Strong emphasis on professional development
- Supportive, people-first work culture
- Training programs and internal career mobility
- Competitive salary and work-life balance
Location: Pune, Maharashtra
Salary Range: ₹7,00,000 – ₹12,00,000 per annum
2. Senior Medical Writer (With Line Management Experience) – Bengaluru/Remote
Job Overview
PrimeVigilance is hiring a Senior Medical Writer with experience in pharmacovigilance aggregate report writing and team leadership. This role focuses on authoring and reviewing regulatory documents across product lifecycle, including PBRERs, DSURs, and RMPs.
Key Responsibilities
- Independently write, edit, and review regulatory and clinical safety documents
- Ensure compliance with internal templates and regulatory standards
- Participate in SOP and quality document development
- Support PV operations related to medical writing
- Mentor and manage Associate Medical Writers
- Maintain continuous self-learning in medical writing and PV guidelines
Qualifications
- Life Sciences degree or equivalent medical/nursing qualification
- Experience writing PBRERs, DSURs, RMPs, and lifecycle safety documents
- Proven line management or team leadership experience
- Ability to handle multiple writing projects
- Excellent command of English
Benefits
- Competitive compensation
- Global cross-cultural collaboration
- Extensive internal training programs
- Flexible/remote work option
- Growth-oriented organizational culture
Location: Bengaluru (Remote option available)
Salary Range: ₹12,00,000 – ₹20,00,000 per annum
How to Apply
Application Link For Senior Benefit/Risk Associate
