Medical Writer III – PrimeVigilance (Pune / Remote)

PrimeVigilance hiring Medical Writer III in Pune/Remote for experienced PV medical writers. Apply now.

As the demand for skilled pharmacovigilance and regulatory writing professionals continues to grow, PrimeVigilance is expanding its global Medical Writing team. This role is designed for experienced medical writers who want to work on high‑impact regulatory and clinical documents that support patient safety, drug development, and global compliance. Candidates with strong expertise in PV medical writing and lifecycle safety documents will find this role a solid step forward in their career.

Company Overview

PrimeVigilance, part of the Ergomed Group, is a global leader in drug safety, medical information, and regulatory services. With teams across Europe, North America, and Asia, the organization supports pharmaceutical and biotechnology partners in delivering high‑quality pharmacovigilance solutions. PrimeVigilance is known for its strong training culture, employee well‑being programs, and long‑standing client relationships across all therapeutic areas, including medical devices.

Job Role & Responsibilities

As a Medical Writer III, you will independently develop, review, and finalize essential clinical and regulatory documents used throughout the product lifecycle. Key responsibilities include:

• Authoring, editing, and reviewing aggregate reports such as PBRERs, DSURs, RMPs, and other PV documents.
• Ensuring accuracy, regulatory compliance, and adherence to internal quality standards.
• Collaborating with cross‑functional safety and regulatory teams to support pharmacovigilance operations.
• Leading and mentoring junior medical writers, providing training and quality oversight.
• Supporting the development and continuous improvement of medical writing templates, SOPs, and documentation workflows.
• Maintaining up‑to‑date scientific and regulatory knowledge relevant to medical writing and drug safety.
• Contributing to process optimization and documentation consistency across global writing teams.

Eligibility / Qualifications

Required:

• Degree in Pharmacy, Medicine, or an advanced Life Science field.
• Proven experience in pharmacovigilance medical writing, including preparation of PBRERs, DSURs, RMPs, and similar documents.
• Strong command of written English and scientific writing standards.
• Ability to manage multiple complex projects with attention to detail.
• Capability to mentor and develop junior team members.

Preferred:

• Experience in global PV operations.
• Familiarity with evolving regulatory guidelines and lifecycle documentation.

Location & Salary

• Location: Pune, India (Remote work option available)
• Employment Type: Full‑time
• Competitive compensation offered by Ergomed Group (details shared during hiring process)

Application Process

Interested candidates can apply directly through the official PrimeVigilance careers portal:
Apply Here

Summary Table

FAQs

1. Can freshers apply for this position?
No. This position requires prior experience in pharmacovigilance medical writing.

2. What types of documents will the writer handle?
PBRERs, DSURs, RMPs, clinical and regulatory safety documents.

3. Is the role fully remote?
Yes, PrimeVigilance allows remote flexibility for eligible Indian candidates.

4. Are mentoring responsibilities included?
Yes. Medical Writer III roles include oversight and training of junior writers.

5. What skills are most valued?
Scientific writing expertise, PV regulatory knowledge, attention to detail, and ability to manage complex documents.

Tagged as: pharma jobs in pune