Shaikh Mudassar Email & Phone Number

Pune, Maharashtra, India

 To perform Pharmacovigilance activities per projectrequirement including but not limited to, intake and trackingincoming - Adverse Events (AE)/endpoint information. Determining initial/update status of incoming events. Database entryincluding coding AE, Products, Medical history and labs, writingnarratives, and other project activities as per internal projecttimelines. Identify quality problems, if any, and bring them to the attention ofa senior team member to meet productivity and delivery standardsand quality standards as per project requirements. To ensure compliance to all project related processes and activities. Process Safety data from various sources according toapplicable regulations, guidelines, Standard Operatingprocedures (SOPs) and project requirements. Attend project team meetings and provide feedback tooperations manager on any challenges/issues orsuccesses.

Bengaluru, Karnataka, India

Receiving adverse event reports from various sources (e.g. healthcare professionals, patients, literature, regulatory authorities).Acknowledging receipt of reports in a timely manner. - Entering Adverse event data into the pharmacovigilance database accurately and efficiently.Ensuring all required fields are completed and adhering to data entry guidelines. - Prioritizing cases based on regulatory reporting timelines and company policies. - Performing quality checks to ensure the accuracy and completeness of entered data.Identifying and correcting discrepancies or missing information.- Communicating with reporters (e.g., healthcare professionals, patients) to obtain additional information or clarify details.Collaborating with internal teams (e.g., safety specialists, medical reviewers) for case processing.- Maintaining detailed and accurate documentation of all received reports and related communications.Ensuring compliance with regulatory requirements and company procedures.- Assisting in the preparation and submission of reports to regulatory authorities as required. Monitoring submission timelines to ensure compliance with regulatory requirements. - Participating in training programs to stay updated on pharmacovigilance regulations and best practices. Ensuring adherence to company standard operating procedure, regulatory guidelines, and industry standards. - Contributing to process improvements to enhance the efficiency and quality of the intake process.Participating in audits and inspections as needed.

Bachelor Of Pharmacy, Pharmacy

Diploma In Pharmacy, Pharmacy

Certificate, Pharmacovigilance &Case Processing