Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

CLINIMINDS IS RECRUITING THIS POSITON FOR THE THE US BASED GLOBAL PHARMA CONSULTING AND PHARMACOVIGILANCE FIRM Role & responsibilities The Associate Director will lead the medical evaluation of Individual Case Safety Reports (ICSRs), oversee the clinical review of aggregate safety reports (e.g., PBRERs, DSURs, ACOs), and provide strategic and medical input in signal detection and benefit-risk assessments for the companys product portfolio, including biosimilars. The role ensures compliance with global regulatory requirements and drives excellence in pharmacovigilance science. ICSR Medical Review Aggregate Report Review Signal Management Cross-functional Collaboration Preferred candidate profile PEOPLE LEADER The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. MINIMUM KNOWLEDGE, SKILLS, AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. Education (MBBS/ MD) or comparable education. Experience and/or Training: A minimum of 10 years of drug safety experience. Should have valuable experience in literature review for both Pre-authorization and Post marketing products. Should have valuable experience in reviewing aggregate reports and signal management activities. Technology/Equipment (Microsoft Proficient).

Our Client is looking for Clinical Data Labeling Specialist with a bioscience background to join our development team. This role is critical in supporting our oncology data pipeline by reviewing and labeling clinical data accurately for structured extraction, AI model training, and research initiatives. Candidates with prior experience in oncology data abstraction or data management roles in clinical trials are strongly preferred. Key Responsibilities: Review and label clinical oncology data from medical records, pathology reports, radiology findings, and molecular/genomic profiles. Ensure consistency, accuracy, and completeness in annotation across datasets used for model training and clinical validation. Apply standardized medical coding systems such as ICD-10, ICD-O-3, RxNorm, and HGVS for labeling and data harmonization. Work closely with medical reviewers, data engineers, and AI teams to refine labeling schemes and contribute to dataset quality control. Document and manage audit trails of labeling activities and highlight inconsistencies or data quality issues. Support ongoing data abstraction tasks for internal research and external oncology projects. Required Qualifications: Bachelors or Masters degree in Biosciences , Biotechnology, Life Sciences, or a related healthcare discipline. Familiarity with medical terminologies, particularly in oncology and related clinical domains. Ability to interpret unstructured clinical text and identify key data points (diagnosis, histology, tumor site, biomarkers, etc.). Preferred Qualifications: Experience in oncology data abstraction , working with clinical trials, cancer registries, or data management teams. Working knowledge and practical application of coding standards such as ICD- 10, ICD-O-3 (Oncology), RxNorm (medications), and HGVS (genetic variant notation) . Knowledge of clinical research workflows. Key Skills: Strong attention to detail and commitment to data accuracy. Analytical mindset with the ability to interpret complex clinical data. Effective communication and teamwork in a fast-paced development environment. Proficient in using Excel.