Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

We are looking for a pharmacovigilance medical writer to join our team.



The Medical Writer will be responsible for medical writing including:
PSURs/PBRERs
PADERs
ACOs
DSURs
RMPs
QC and review of all written output from the operations team as required
Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
Complete quality documentation of aggregate reports
Attending kick off meetings with current clients as required
Attending audits and inspections as required
Providing aggregate report training

Qualifications
MD, pharmacy or Life Science degree (Masters or PhD is desirable)
Robust previous experience in Pharmacovigilance (case processing, signal detection or risk management) within ideally a CRO setting
Ability to manage multiple and varied tas

📌 Medical Writer Ii Pune
🏢 PrimeVigilance
📍 Pune