Daljeet Singh Email & Phone Number

Chandigarh, India

Responsible for the preparation of aggregate safety reports, including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs) and Drug Safety Update Reports (DSURs).Collaborate with the Global Patient Safety (GPS) Aggregate and Risk Management (ARRM) product lead and GPS Physicians on product safety teams and support risk management activities, including signal detection and tracking, Regulatory Authority requests, and maintenance of Risk Management Plans (RMPs).

India

Performing QC/QA of ICSRsReviewing the cases to verify the below points:- Case validity- Event term selection and MedDRA coding- Event seriousness- Coding of products- Listedness assessmentPerforming quality check to verify critical fields (including reportability) as well as conformity to E2B standardsEnsuring data consistency and medical cohesiveness of the narrativesVerifying if action items have been created appropriately in the Safety DatabaseReviewing if all key activities are documented by the Case Reviewer in the contact log inthe Safety DatabaseVerifying cases that are required to be routed to Medical Review workflow step arecorrectly identified by the Case ReviewerEnsuring compliance of ICSRs with client and regulatory requirementsEnsuring high quality of assigned work in accordance with quality parametersPerforming trend analyses of the data, as applicableHighlighting any issues emerging from the QC/QA results to the Team Leads/Project Manager and/or client contacts, as required

Mohali

Principle responsibilities:• Ensures clear and accurate data capture of adverse events cases (including non-serious events and serious cases from spontaneous origins, and unrelated and related cases from clinical origin). And appropriate medical assessment (including company causality, labeling, and company comments) of single AE reports in accordance with the customer’s conventions /guideline and standard processing procedures.• Triages the cases allocated by the business co-coordinator.• Reviews of ancillary documentation accompanying adverse event reports and identifies the relevant information and electronic capture on the safety database.• Single case initiation.• Interacts with internal or external contracts to resolve issues related to the processing of adverse events reports.• Maintains excellent knowledge of the AE safety profile of assigned drugs, labeling documents, data capture conventions and guidelines and the costumer procedures.• Maintains awareness of global regulatory reporting obligations and organizes workload to ensure compliance with internal and regulatory timelines for adverse event reporting.• Provides input, where applicable and as necessary, into data capture conventions/guidelines/procedures/coding manuals• Learning and applying of standard operating procedures (SOP’s) involved in good clinical practice.

Baddi , Himachal Pradesh , India

I did my one month industrial training from here in manufacturing, packaging, QA and QC, Etc.

Master Of Pharmacy, Pharmaceutics And Drug Design, 8.59 Cgpa

Bachelor Of Pharmacy - Bpharm, Pharmacy, 73%