vacancies

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.