Medical Writer II

ERGOMED

Pharmacovigilance medical writer responsible for medical writing and quality documentation at PrimeVigilance, a pharmacovigilance service provider. Collaborating with project managers and ensuring compliance in documentation.

Posted 6/27/2026full-timeRemote • 🇮🇳 IndiaMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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 new clients as required
Attending audits and inspections as required
Providing aggregate report training

Requirements

What you’ll need

MD, pharmacy or Life Science degree (Masters or PhD is desirable)
Strong previous experience in Pharmacovigilance (case processing, signal detection or risk management) within ideally a CRO environment
Ability to manage multiple and varied tasks and prioritize workload with attention to detail
Ability to effectively train and mentor Associate Medical Writers
Must be a strong team player
Fluency in English, an additional language is a benefit

Benefits

Comp & perks

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingPSURsPBRERsPADERsACOsDSURsRMPsquality documentationPharmacovigilancecase processing

Soft Skills

attention to detailability to manage multiple tasksprioritizationtrainingmentoringteam playercommunicationorganizational skillsproblem-solvingcollaboration

Certifications

MDPharmacy degreeLife Science degreeMastersPhD