Dr. Harpreet Pal Singh

Worded for Medical and Scientific Services as Drug Safety Associate-II provider at Parexel India with below general duties:

• Accurate documentation of adverse events and other safety data related to client specific products across all therapeutic areas.
• Trained in determining expectedness of adverse events in accordance with various labeling documents (such as summary of product characteristics (SPC), core data sheet (CDS), investigator's brochure (IB) etc.), writing case summaries, assessing causalities, and writing company comments if required.
• Experience of monitoring the standardized ICSR lateness reasons and associated
• corrective and preventive action (CAPA) plans.
• Prioritizing workload to meet projected deadline and meeting KPIs.
• Requesting follow ups to provide full clinical picture of possible adverse drug reactions.
• Performing reconciliations and batch amendments
• Assessment validations of reports with potential AEs resulting from medical inquiries, quality related complaints and device malfunctions
• Handled compliance reports and late case investigations
• Prepared and presented educational material for discussion in department meetings.
• Assisted in development of medical and database conventions by pointing out problematic topics and issues
• Expertise in handling the ERP systems (Enterprise Resource Planning)
• Maintain computerized record management systems to store and process data, such as personnel activities and information, and to produce reports.
• Develop and implement organizational policies and procedures for the facility or medical unit at CT sites.
• Establish work schedules and assignments for staff, according to workload, space and equipment availability at CT sites.
• Maintain communication between medical staff, and department by attending meetings and coordinating interdepartmental functioning.
• Maintain awareness of advances in medicine, diagnostic and treatment equipment, data processing technology.
• Develop or expand and implement programs or health services that promote rehabilitation, and community health.
• Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
• Fluent in Veeva Vault system
• Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
• Maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations
• Expertise in maintaining an awareness of global reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
• Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients' policies. Responding to clients/customers in a timely manner.