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PV Medical Writer II Job in Pune (Remote)

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PrimeVigilance

MD / Pharm.D / M.Pharm / Life Sciences degree/ Masterโ€™s or PhD preferred

Pune (Remote)

3 - 5 Years+

Verified Job

Online Application
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Looking for a PV Medical Writer job in Pune or a remote pharmacovigilance writing role in India? Hereโ€™s an excellent opportunity with PrimeVigilance, a globally recognized pharmacovigilance service provider.

This PV Medical Writer II role is ideal for professionals with experience in aggregate report writing, pharmacovigilance, and regulatory documentation. If you have expertise in PSUR, PBRER, DSUR, and RMP writing, this job offers strong career growth in a global CRO environment.


๐Ÿ” Job Overview

  • Position: PV Medical Writer II
  • Company: PrimeVigilance (Ergomed Group)
  • Location: Pune, Maharashtra, India (Remote Available)
  • Department: Medical Writing
  • Job Type: Full-Time
  • Industry: Pharmacovigilance / CRO / Medical Writing

๐Ÿงช Key Responsibilities โ€“ PV Medical Writer

As a Pharmacovigilance Medical Writer, you will be responsible for:

  • Writing and reviewing aggregate safety reports:
    • PSURs / PBRERs
    • DSURs
    • PADERs
    • Risk Management Plans (RMPs)
    • Ad-hoc Clinical Outputs (ACOs)
  • Performing quality control (QC) of medical writing deliverables
  • Supporting project managers with report scheduling
  • Ensuring compliance with SOPs, regulatory guidelines, and templates
  • Participating in client meetings, audits, and inspections
  • Delivering training and mentoring to associate medical writers
  • Collaborating with Quality & Compliance teams for continuous improvement

๐ŸŽ“ Eligibility Criteria

To apply for this PV Medical Writer II job in India, candidates should have:

Education:

  • MD / Pharm.D / M.Pharm / Life Sciences degree/ Masterโ€™s or PhD preferred

Experience:

  • Strong experience in pharmacovigilance:
    • Case processing
    • Signal detection
    • Risk management
  • Prior experience in a CRO (Contract Research Organization) is highly desirable

Skills Required:

  • Expertise in aggregate report writing (PSUR, DSUR, RMP)
  • Strong attention to detail & documentation skills
  • Ability to manage multiple projects simultaneously
  • Excellent English communication skills
  • Team collaboration & mentoring ability

๐Ÿ’ผ Salary & Benefits

  • Estimated Salary: โ‚น8,00,000 โ€“ โ‚น14,00,000 per annum
  • Remote work flexibility
  • Global exposure with international teams
  • Strong training & career development programs
  • Supportive and inclusive work culture
  • Opportunities in medical writing and pharmacovigilance leadership roles

๐ŸŒ Why Join PrimeVigilance?

PrimeVigilance is a leading pharmacovigilance and medical writing company, known for:

  • Global presence across Europe, North America, and Asia
  • Expertise in drug safety, regulatory affairs, and medical information
  • Strong focus on employee well-being and career growth
  • Collaborative, diverse, and inclusive work environment

๐Ÿ“ฉ How to Apply

Application Link

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