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Senior Benefit/Risk Associate

2-4 years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Benefit/Risk Associate – PrimeVigilance (Ergomed Group)

Location: Pune, Maharashtra, India
Employment Type: Full-time
Department: Benefit-Risk Management

About the Company

PrimeVigilance, a part of the Ergomed Group, is a leading global mid-sized pharmacovigilance service provider established in 2008. With teams across Europe, North America and Asia, the company delivers expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance partners with pharmaceutical, biotechnology and medical device companies worldwide, supporting products across all therapeutic areas. The organisation is known for its strong focus on employee development, training, well-being, and a balanced work culture, enabling high-quality service delivery and long-term client relationships.

Position Overview

The Senior Benefit/Risk Associate will contribute to pharmacovigilance and signal management activities within project teams. This role requires strong scientific aptitude, hands-on experience in signal detection, and familiarity with signal management tools. The successful candidate will support global clients, working on clinical trial and post-marketing safety projects of varying scales.

Key Responsibilities

  • Participate in signal detection activities, including system and process set-up.

  • Review line listings and datasets required for signal detection reports.

  • Draft complex signal detection reports and perform quality control checks.

  • Evaluate, categorize and prioritize potential safety signals.

  • Recommend actions and follow-up strategies for identified signals.

  • Support communication and documentation required for regulatory authority submissions.

  • Maintain accurate documentation, tracking tools and project records.

  • Collaborate with cross-functional teams to ensure compliance with PrimeVigilance procedures and global regulatory requirements.

Required Qualifications & Experience

  • Bachelor’s or Master’s degree in Life Sciences or Biomedical disciplines, preferably Pharmacy.

  • Prior experience in pharmacovigilance is mandatory.

  • Minimum 2–4 years of experience in signal detection, signal evaluation, and use of signal management tools.

  • Strong understanding of pharmacovigilance processes, regulatory expectations, and safety data management.

  • Excellent analytical, organizational, time-management and multitasking abilities.

  • Strong verbal and written communication skills in English (minimum B2 level).

  • Attention to detail and ability to work efficiently in a fast-paced, collaborative environment.

Preferred Skills

  • Demonstrated ability to contribute to patient safety and continuous improvement.

  • Experience in working within global project teams.

  • Ability to manage workload independently while ensuring accuracy and compliance.

Why Join PrimeVigilance?

PrimeVigilance offers a workplace built on diversity, equity and inclusion. The culture emphasizes collaboration, growth, and a human-first approach.
Employees benefit from:

  • Comprehensive internal training and clear career progression pathways.

  • A supportive and professional working environment.

  • Opportunities to work with global teams across multiple regions.

  • A strong organisational culture rooted in quality, integrity, agility, trust, belonging, and collaborative partnerships.

Core Values

  • Quality

  • Integrity and Trust

  • Drive and Passion

  • Agility and Responsiveness

  • Belonging

  • Collaborative Partnerships