The candidate should have a first-class post-graduate degree in Biochemistry / Biotechnology / Molecular & Human Genetics /Zoology / Animal Science / Life Sciences with qualified NET / GATE or equivalent examination.

Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.

To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate

University / College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution

Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development process and production of Data Management deliverables

Responsible for the companys drug surveillance program including the necessary follow-up, assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.

Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.

This role serves as a key contributor to regulatory operations by ensuring the accuracy, integrity, and compliance of regulatory information used for global submissions, registrations, product maintenance, and post-market activities.

Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development

Perform setup activities including CRF creation, edit check specification creation, and User Acceptance Testing.

Experience in injectables and sound knowledge of sampling, in-process checks, line clearance activities during manufacturing. Anthea Pharma Interview

Exposure of handling manufacturing activities of OSD manufacturing activity (Granulation, Compression, Coating and Packing)

Oversee validation and qualification activities related to manufacturing, processes, cleaning, equipment and systems. Ensure effective handling of market complaints, product quality issues and investigations.

Formulation and process development activities for parenteral pharmaceutical products. Pre-formulation, compatibility, stability and optimization studies.

India is expanding domestic manufacturing of critical pharmaceutical raw materials through the Production Linked Incentive (PLI) Scheme for Bulk Drugs, with five greenfield projects now commissioned across the country.

The Government of India has approved financial assistance of around ₹1,600 crore for 41 pharmaceutical and medical technology projects under the first round of the Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) initiative.

The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. This innovative device may reduce the need for repeat open-heart surgeries in children with heart defects, reflecting the Trump Administration’s commitment to bringing breakthrough medical technologies to market as quickly and safely as possible.

A large Scandinavian phase 3 clinical trial has found that starting aspirin after curative-intent treatment for colorectal cancer that has spread to the liver does not reduce the risk of cancer recurrence or death. The findings come from the ASAC trial, conducted across hospitals in Norway, Sweden and Denmark.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi USA LLC over significant Current Good Manufacturing Practice (CGMP) violations identified at the company's sterile drug manufacturing facility in Melrose Park, Illinois.