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ERGOMED

Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.

PV Medical Writer II

Medical writerMedical writerFull TimeRemoteSeniorTeam 1,001-5,000Since 1997H1B No SponsorCompany SiteLinkedIn

Location

India

Posted

79 days ago

Salary

0

Seniority

Senior

Postgraduate DegreeEnglish

Job Description

PV Medical Writer II

ERGOMED

• 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

Job Requirements

  • 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

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment

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