Sobin James Email & Phone Number

Kitchener, On, Ca

Mississauga, Ontario, Canada

- Manage Adverse events/Pharmacovigilance inbox and conduct follow-ups as required.- Perform data entry of safety events into the internal database (CRM). Retrieve source documents from the database. - To assist with collection, processing, quality check, and reporting of Safety events (initial and follow-up) as per the program requirements. - To conduct an investigation for quality issues and collect all the information to complete CAPA.

Guelph, Ontario, Canada

• Ensure quality and compliance by: Maintaining a sound understanding of GMPs and GDPs, rigorously following all compliance procedures applicable to the tasks being completed. • Process raw material according to the validated process identified on batch record as per cGMP guidelines, SOPs, and Safety parameters.• Exercise the highest level of integrity in the tasks performed. Report all deviations or excursions from processes in a timely and prompt manner.• Perform all documentation, including electronic records (PAS-X & SAP) related to processes being performed• Report all deviations, OOT or OOS, and applying all newly introduced CAPA.• Generating and retention of formulation/processing records according to Good Documentation Practices.

Kochi, Kerala, India

• Ensure document compliance according to GMP and GDP• Development, review, revision, and implementation of SOPs as required• Manage deviation reports• Maintain the inventory as per the target for the quarter• Maintain QC master documents for all registered products• Manage and evaluate (trending) product complaints, deviations, Corrective Actions, and Preventative Actions (CAPAs) • Ensure the records are maintained as per the statutory requirements.

Muscat

Duties and Responsibilities• Manages the consolidated inventory program, the drug accountability program and controlled substances program for the Pharmacy▪ Create and update policies and SOP's▪ Responsible for Drug Therapy Management▪ Retain the records of Non-Psychotropic, Psychotropic and Narcotic medicines as per the ministry regulations.▪ Manage budget and allocate funds within the facilities.▪ Preparation of monthly/weekly inventory reports for MIS reporting & meeting.▪ Provides inputs to management for store strategies and ensure all plans are executed to result in maximized sales, profitability and commercial performance of pharmacies.▪ Responsible for developing the pharmacist indulged in sales (Team building, motivating and training them on tactical selling).▪ In-depth knowledge of Insurance billing, approval and reconciliation process▪ Ensure all pharmacists are trained and following the guideline and SOP provided.▪ Responsible for identifying, correcting, and documenting pharmacy errors/incidents

Hyderabad Area, India

Perform quality check & review of benefits plans.Ensures the quality of documents that objectively & accurately represent the planning data.Comply with the established performance metrics.Ensures that deliverables are met as per client specification & planned timelines.Maintaining & filling of Quality Review check list, Error tracker & lessons learnt sheets of each project.Work effectively with other Quality Reviewers & communicating project information in timely manner.Participates activley in any activity related to process knowledge.Generate queries to clarify & improve the quality of data.Ensures the 100% quality of project within time limit.

Bangalore

• Overseeing clinical practice of the site and ensuring multiple affiliates comply with the protocol.• Screening patients to determine study eligibility criteria by reviewing patient medical records and interviewing the subjects.• Providing education and instruction of study medication use, administration, storage, side effects, and notifying adverse drug reactions to the study site.• Maintaining complete and accurate data collection in case report forms and source documents.• Initiating and/or expediting requests for consultation, special tests, or studies following the investigator's approval.• Obtaining and organizing data such as test results, diaries/cards, or other necessary information for the study.

Kottayam Area, India

• Coordinating the day-to-day activities of the research study team specifically engaged in carrying out the research protocol.• Coordinating and actively recruiting and formally consents subjects for enrollment.• Maintain records for the investigational products as required by the law

Masters, Pharmacology And Biotechnology

B-Pharmacy, Pharmacology, Pharmaceutical Science, Formulative Pharmacy