Job Title: Pharmacovigilance Medical Writer II
Location: Pune, Maharashtra, India
Employment Type: Full-Time
Department: Medical Writing
Company: PrimeVigilance (part of Ergomed Group)
Company Overview
PrimeVigilance, established in 2008, is a global pharmacovigilance service provider with teams across Europe, North America, and Asia. The company specializes in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
PrimeVigilance serves pharmaceutical and biotechnology partners across all therapy areas, including medical devices. The organization emphasizes employee training, development, well-being, and work-life balance to maintain high-quality client services.
Purpose of the Role
The Pharmacovigilance Medical Writer II will be responsible for authoring, reviewing, and ensuring quality of pharmacovigilance aggregate reports, while supporting project teams and mentoring junior writers.
Key Responsibilities
Medical Writing & Reporting
Prepare and review pharmacovigilance documents including:
PSURs / PBRERs
PADERs
Aggregate Clinical Overview (ACO)
DSURs
Risk Management Plans (RMPs)
Conduct quality control (QC) of outputs from the operations team.
Document quality processes related to aggregate reports.
Project Support
Assist project managers in scheduling aggregate reports.
Participate in client kickoff meetings as required.
Attend audits and inspections when necessary.
Training & Process Improvement
Provide training on aggregate report writing.
Identify areas for improvement in SOPs, templates, and operational guidance in collaboration with Quality, Compliance, and Training Managers.
Mentor and guide Associate Medical Writers.
Qualifications & Experience
MD, Pharmacy, or Life Sciences degree (Master’s or PhD preferred).
Strong experience in pharmacovigilance (case processing, signal detection, or risk management), preferably in a CRO environment.
Ability to manage multiple tasks, prioritize workload, and maintain attention to detail.
Strong team player with mentoring experience.
Fluency in English; knowledge of additional languages is a plus.
Additional Information / Company Culture
PrimeVigilance emphasizes diversity, equity, and inclusion.
Offers training and career development opportunities.
Promotes a friendly, supportive, and collaborative working environment.
English is the primary language for communication within the organization.
Core Values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
The role provides the opportunity to contribute to patient safety and make a meaningful impact on patients’ lives.
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