Medical Writer Jobs in India: PrimeVigilance is Hiring a Pharmacovigilance Medical Writer II in Pune office – Apply Now
Are you looking for Medical Writer Jobs in India? PrimeVigilance, part of the Ergomed Group, is seeking a Pharmacovigilance Medical Writer II to join its Pune office. This role involves preparing and reviewing aggregate safety reports including PSURs, PBRERs, DSURs, RMPs, and more, while supporting regulatory compliance and training initiatives. Ideal candidates have a background in pharmacy, medicine, or life sciences, experience in pharmacovigilance, and a keen eye for detail to ensure high-quality medical writing outputs.
Job Details:
- Job Title: Pharmacovigilance Medical Writer II
- Location: Pune, Maharashtra, India
- Employment Type: Full-time
- Department: Medical Writing
About the Company:
PrimeVigilance, part of the Ergomed Group, is a leading global pharmacovigilance service provider established in 2008. Specializing in medical information, pharmacovigilance, regulatory affairs, and quality assurance, the company partners with pharmaceutical and biotechnology organizations to ensure patient safety and regulatory compliance worldwide. With offices across Europe, North America, and Asia, including Pune, India, PrimeVigilance delivers high-quality support for all therapy areas, including medical devices. The company is renowned for fostering a collaborative and employee-friendly work environment, emphasizing staff development, training, well-being, and work-life balance. By investing in its workforce, PrimeVigilance ensures exceptional service quality and long-term partnerships with clients globally.
Qualifications:
MD, M.Pharm, or Life Sciences degree (Masters/PhD preferred).
Skills:
- Strong experience in pharmacovigilance, preferably within a CRO environment.
- Excellent organizational, multitasking, and prioritization skills.
- Ability to train and mentor team members effectively.
- Strong team player with fluency in English; additional languages are a plus.
Key Responsibilities:
- Prepare and review PSURs, PBRERs, PADERs, DSURs, RMPs, and ACOs.
- Conduct quality checks and reviews of written outputs from operations teams.
- Support project managers in scheduling and tracking aggregate report submissions.
- Identify areas for process improvement and assist with training and SOP clarifications.
- Complete quality documentation for aggregate reports.
- Attend client kick-off meetings, audits, and inspections as required.
- Provide aggregate report training and mentor associate medical writers.
