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Principal Investigator

Rusan Pharma Ltd
Rusan Pharma Ltd
2-7 years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Healthcare & Life Sciences - Clinical Investigation Manager
Company: Rusan Pharma
Location: Mumbai, Maharashtra, India


Role & Responsibilities

  • Plan and manage the department's budget, monitoring actual expenditure against the allocated budget.
  • Prepare monthly and quarterly study plans in consultation with the unit head, including contingency plans to accommodate any unexpected changes.
  • Oversee the day-to-day operations of the department, ensuring smooth functioning.
  • Implement quality systems to ensure compliance with regulatory and statutory requirements and align with international GLP practices.
  • Facilitate the timely scheduling of Ethics Committee meetings for project approvals and ensure all committee queries are promptly addressed with appropriate documentation for timely approval.
  • Review and authorize study-related documents and procedures.
  • Continuously introspect and implement review mechanisms to minimize observations and ensure compliance.
  • Encourage and perform online documentation of study-related CRFs and documents to meet project timelines.

Preferred Candidate Profile

  • Education: M. Pharm, MBBS, BHMS
  • Experience: 2-7 years in clinical investigation
  • Skills & Expertise:
    • Strong understanding of clinical trial regulations (FDA), ICH guidelines, GCP principles, and Good Clinical Practice (GCP).
    • Experience in clinical investigation and pharmacovigilance.

About the Company

Rusan is a research-driven pharmaceutical company with manufacturing units in India and a global marketing presence for Pharmaceutical Formulations, Active Pharmaceutical Ingredients, and Intermediates. With approvals from Health Canada, EUGMP, and EDQM, Rusan is dedicated to producing high-quality pharmaceutical products. The company’s corporate office is located at Kandivli (West), Mumbai, with state-of-the-art manufacturing facilities in Ankleshwar, Dehradun, and SEZ Kandla.


Employment Type: Full Time, Permanent
Role Category: Healthcare & Life Sciences - Other