Medreich, part of the globally renowned Meiji Group, is a leading pharmaceutical company based in Bangalore. The company has built a strong reputation for providing high-quality pharmaceutical products and services. With a legacy of more than four decades, Medreich is committed to contributing to global healthcare through innovation and operational excellence.

As part of its continued growth, Medreich is seeking qualified professionals for its Pharmacovigilance department. This role provides an exciting opportunity for individuals with experience in pharmacovigilance, especially those skilled in xEVMPD activities.

Job Responsibilities in Pharmacovigilance The selected candidate will play a crucial role in ensuring drug safety and compliance. Key responsibilities include:

1. Receipt and Assessment of EVWEB ICSRs: Efficiently managing the Individual Case Safety Reports (ICSRs) received through EVWEB for accurate reporting and analysis.
2. Medical Literature Monitoring (EMA-MLM): Conducting medical literature reviews in line with European Medicines Agency (EMA) guidelines to identify relevant safety information for marketed products.
3. Electronic Reaction Monitoring Report (eRMR): Overseeing and analyzing eRMRs for identifying potential adverse drug reactions and ensuring patient safety.
4. Database Management (xEVMPD Activities): Maintaining and updating key databases like QPPV (Qualified Person Responsible for Pharmacovigilance), SmPC (Summary of Product Characteristics), and MAH (Marketing Authorization Holder) information, ensuring compliance with regulatory requirements.

Required Qualifications Candidates interested in this Pharmacovigilance role should have the following qualifications:

• A degree in Pharmacy, Life Sciences, or related fields.
• 1 to 4 years of experience in pharmacovigilance or related pharmaceutical activities.
• Familiarity with xEVMPD database operations and knowledge of global pharmacovigilance regulations.
• Strong understanding of EVWEB ICSR handling and related safety documentation processes.

Desired Skills The ideal candidate should possess the following skills:

• Experience with xEVMPD: Comprehensive knowledge of extended EudraVigilance Medicinal Product Dictionary (xEVMPD) operations and database management.
• Strong Analytical Skills: Ability to assess Individual Case Safety Reports (ICSRs) and identify safety signals.
• Attention to Detail: Ensuring accurate reporting and compliance with pharmacovigilance regulations.
• Communication Skills: Effective communication in reporting and updating safety information.
• Problem-solving: Proactive approach to managing safety data and ensuring regulatory adherence.

How to Apply Interested candidates who meet the qualifications and are passionate about contributing to drug safety are encouraged to apply. Please send your updated resume to sekhar.s@medreich.com.