Pharmacovigilance Medical Writer II

Primevigilance

6 - 7 years

8 - 9 Lacs

pune

Posted:2 days ago| Platform:

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Skills Required

training cro pharmacy scheduling pharmacovigilance case processing risk management medical writing quality documentation quality compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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

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