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Macleods Pharmaceutical Ltd Hiring Compliance Report Activity – Pharmacovigilance & Medical Services

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Macleods Pharmaceuticals has announced multiple openings at its R&D center in Andheri, Mumbai for experienced pharmacy professionals. The company is currently hiring for Pharmacovigilance Compliance and Medical Services profiles.

This latest Macleods Pharmaceuticals recruitment drive is ideal for candidates with M.Pharm in Pharmacology or Pharmaceutics who are looking for pharma jobs in Mumbai with exposure to pharmacovigilance, regulatory compliance, medical writing, and global regulatory documentation.

Candidates with prior experience in PV operations, medical services, clinical overview preparation, SOP management, compliance reporting, and regulatory dossier writing are encouraged to apply.


Available Job Roles at Macleods Pharma

1. Website Review & Compliance Report Activity – Pharmacovigilance

Experience Required

  • 1 to 2 Years

Qualification

  • M.Pharm (Pharmacology/Pharmaceutics)

Key Responsibilities

Selected candidates will be responsible for:

  • Daily review of regulatory and safety websites including Europe, UK, WHO, India, Kazakhstan, South Africa, Ukraine, and ROW markets
  • Monitoring pharmacovigilance safety updates and sharing information with relevant stakeholders
  • Coordination with:
    • Case Processing Teams
    • PSUR Teams
    • Signal Management Teams
  • SOP updates and compliance documentation activities
  • Coordination with QPPV and Local Responsible Persons (LRP)
  • Archival of emails and PV-related documents
  • Drafting compliance reports as per SOP and templates
  • Conducting compliance meetings and MOM preparation
  • Tracking action items and stakeholder follow-up

Required Skills

Candidates should have knowledge of:

  • GVP Modules
  • MHRA Guidelines
  • EU & UK Pharmacovigilance Regulations
  • USFDA Guidelines
  • India and ROW PV Regulations
  • PSMF
  • ICSR
  • PSUR
  • RMP

Strong communication, teamwork, and organizational skills are also required.


2. Medical Services Department

Experience Required

  • 2 to 3 Years

Qualification

  • M.Pharm / M.Pharm (Pharmacology)

Key Responsibilities

The Medical Services role includes:

  • Preparation of Module 2.4 Non-Clinical Overview and Study Matrix
  • Preparation of Module 2.5 Clinical Overview and Study Matrix
  • Drafting:
    • Pack Insert (PI)
    • Patient Information Leaflet (PIL)
    • Summary Product Characteristics (SPC)
  • Artwork approval activities
  • Literature searches for clinical, non-clinical, and formulation data
  • Product monograph preparation
  • Preparation of rationales for FDC, efficacy, and dosing
  • Monitoring in-house BA/BE studies

Required Skills

Applicants should possess:

  • Medical writing expertise
  • Regulatory documentation experience
  • Knowledge of clinical and non-clinical dossier preparation
  • Scientific literature review skills
  • Attention to detail and documentation accuracy

Job Location

  • Andheri, Mumbai

Salary Expectations

Based on current industry standards for experienced M.Pharm professionals in Mumbai:

  • Pharmacovigilance Compliance Role: ₹4.5 LPA – ₹7 LPA
  • Medical Services Role: ₹5.5 LPA – ₹8.5 LPA

Salary may vary depending on experience, domain expertise, and interview performance.


How to Apply

Interested and eligible candidates can send their updated resume to:

Email: adityab@macleodspharma.com

Subject Line

  • For PV Role: Website Review and Compliance Report Activity
  • For Medical Services Role: Medical Services

Important Note: Freshers are not eligible for these openings. Only experienced candidates should apply.

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