Dr. Navdeep Kaur Email & Phone Number

Pune, Maharashtra, India

•Perform medical review of the cases according to clients Standard operating procedure (SOPs) and liaising with the client as required. •Writing pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing the company causality. • Lead medical assessment of SAE reports, including case narrative accuracy, MedDRA coding, medically relevant queries, seriousness, expectedness, causality, and reportability. •Develop and review to variety of aggregate reports for global regulatory submission that include, PADERs and Annual Safety Reports. •Participate in detection of signal in different therapeutic products. •Prepare search criteria for specific products for valid case reports and different aggregate reports such as annual reports• Screened, reviewed, and triaged the literature search results for product safety assessment and potential safety issues. •Training and mentorship- Provide training and guidance to the case processing team on medical aspects of case processing.

Gurugram, Haryana, India

Management of activities related to the processing (case validation, duplicate detection, identification and creation of split cases (where required), data entry in the Safety Database) of ICSRs in accordance with the applicable regulatory requirements  Performing Medical Dictionary for Regulatory Activities (MedDRA) coding in accordance with “MedDRA Term Selection: Points to Consider”  Ensuring high quality of assigned work in accordance with client and project quality parameters  Being well-versed with safety profile of assigned drugs, labelling documents, ICSR processing conventions, guidelines, procedures and international safety regulations, as applicable  Organizing workload to ensure compliance with internal and regulatory timelines  Interacting with internal or external contacts to resolve queries and issues related to the assigned work  Maintaining awareness of international regulations for drugs and devices Providing support in audits, inspections and inspection readiness activities, as required  Performing additional activities, such as mentorship support and others as directed

Gurugram, Haryana, India

New Delhi Area, India

• Assist with the processing of case (Spontaneous, literature and clinical) as required in compliance with applicable regulations and SOPs, and as requested by the Pharmacovigilance Scientist or above. Prepare case narratives as appropriate.• Triage of cases for completeness, accuracy and redaction, determining expectedness against the reference safety information and appropriateness for expedited reporting.• Prepare and submit case notifications to customers. Identify and send case follow-up requests.• Entry of safety data onto the safety databases and tracking systems. Maintain a strong understanding of the client’s safety database conventions or client specific database conventions, as appropriate.• Coding of adverse events, medical history and medications either manually or using the auto-encoder.• Being aware of and working to the standards appropriate to the project (CRO or customer).• Literature Review and assist with weekly and ad-hoc global literature searches as required, ensuring adherence to timelines and processes specified in SOPs and project-specific Safety Plans.• Assist with review and classification of literature abstracts and articles under the supervision of the PV Scientist or above.• Authoring PADERs as per clients requirement

Amritsar, Punjab, India

Amritsar Area, India

A full one year rotary internship in all clinical and non clinical departments.Performing procedures independently including teeth restoration,Root canal treatment,tooth extraction,fabrication of full and partial dentures and taking descriptive history for preparing a complete treatment plan

Bachelor Of Dental Surgery, Bds

Post Graduate Diploma In Mental Health