PrimeVigilance, a globally recognized pharmacovigilance (PV) and regulatory services company, is hiring a Pharmacovigilance Medical Writer II in Pune, India.
This opportunity is ideal for candidates with strong PV writing experience looking to work in a global, supportive environment with exposure to aggregate safety reports, risk management documents, and quality compliance.
If you’re passionate about drug safety, regulatory documentation, and scientific medical writing, this role offers a rewarding career path with excellent growth opportunities.
Key Responsibilities
As a Pharmacovigilance Medical Writer II, you will be responsible for:
- Preparing high-quality PV aggregate reports including:
- PSURs / PBRERs
- PADERs
- DSURs
- RMPs
- Annual Company Reports (ACOs)
- Performing QC review of safety deliverables.
- Supporting Project Managers in report scheduling and planning.
- Collaborating with Quality and Training teams to improve SOPs, templates, and training materials.
- Managing documentation quality and ensuring compliance.
- Attending client kick-off meetings, audits, and inspections.
- Training and mentoring Associate Medical Writers.
Qualifications
To apply for this PV Medical Writer job in Pune, candidates must have:
- MD / Pharmacy / Life Science degree (Master’s/PhD preferred)
- Strong hands-on experience in Pharmacovigilance (case processing, signal detection, risk management)
- Experience in a CRO environment preferred
- Excellent English communication and scientific writing skills
- Ability to prioritize multiple tasks and deliver accurately
- Mentoring or training experience is a bonus
- Team-oriented mindset with strong attention to detail
Why Join PrimeVigilance?
PrimeVigilance offers a work culture centred around growth, inclusion, and employee well-being:
- Global exposure across Europe, North America & Asia
- Extensive training & internal career development
- Friendly, collaborative international team
- Strong focus on work-life balance and mental well-being
- Company values: Quality, Integrity, Trust, Agility, Belonging, Collaboration
How to Apply
