Macleods Pharmaceutical Ltd. is seeking a qualified and experienced Aggregate Report Reviewer to join their team in the Pharma Covigilance department at their R&D facility in Andheri, Mumbai. This role involves quality reviewing PSUR, PBRER, and ACO reports, as well as preparing and tracking reports for submission to regulatory authorities.
About the Role
As an Aggregate Report Reviewer, you will play a critical role in ensuring the quality and accuracy of pharmacovigilance reports.
Your primary responsibilities will include:
Quality Review: Quality reviewing PSUR, PBRER, and ACO reports to ensure compliance with regulatory requirements.
Report Preparation: Preparing and tracking reports for submission to regulatory authorities, including managing calendars and allocations.
Training and SOPs: Preparing and training SOPs and SFGs as per guideline requirements.
Query Handling: Handling queries from agencies and authorities and preparing responses.
Requirements
Education: M. Pharma (Pharmacology) or equivalent degree.
Experience: 1-2 years of experience in reviewing aggregate reports, preferably in a pharmacovigilance setting.
Technical Skills: Proficiency in Microsoft Office, including Word and PowerPoint.
Skills:
Strong analytical and problem-solving skills.
Excellent communication and writing skills.
Ability to work independently and prioritise tasks effectively.
What We Offer
Career Growth: Opportunities for professional development and growth in a leading pharmaceutical company.
Collaborative Environment: A dynamic and supportive team environment.
Competitive Benefits: Competitive salary and benefits package.
Why Choose Macleods Pharmaceutical Ltd.?
Industry Leader: Opportunity to work with a leading pharmaceutical company.
Professional Development: Opportunities for professional growth and development.
Innovative Culture: A company that values innovation, quality, and people.
📧 Interested candidates can send their resumes to adityab@macleodspharma.com
Subject Line: Aggregate Report Reviewer – Application
Note: This is a work-from-office position. Only candidates with relevant experience will be considered.