Seema Sharma Chatterjee Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bangalore, Karnataka

-Evaluate safety data and signals for assigned products, Support Global Safety Officer (GSO) safety related activities for assigned products and manage ongoing core signal detection activities for GSO review.-Evaluate safety data from multiple sources. Author periodic signaling reports. Coordinate, author and propose responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with GSO.-Core member of the Safety Management Team… Show more -Evaluate safety data and signals for assigned products, Support Global Safety Officer (GSO) safety related activities for assigned products and manage ongoing core signal detection activities for GSO review.-Evaluate safety data from multiple sources. Author periodic signaling reports. Coordinate, author and propose responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with GSO.-Core member of the Safety Management Team, including setting agenda, producing necessary data outputs, requesting contribution of all functions, preparing slide presentations, facilitating discussions & documenting conclusions.-Support the preparation and maintenance of safety sections of the Company Core Data Sheet. In partnership with the GSO, provide strategic input and review of applicable sections of the PBRER and DSUR to ensure that aggregate data analyses is consistent with overall product safety profile.-Provide safety content for new drug applications and other regulatory filings including review of the safety and support to GSO for benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation.-Collaborate with the GSO in preparation and authoring developmental Risk Management Plans (DRMPs), safety sections of the EU Risk Management Plan (RMPs) and Risk Evaluation and Mitigation Strategy Plans (REMS). Represent Pharmacovigilance on study teams, cross functional product teams, etc. when assigned as the delegate for the GSO. Show less

Bengaluru Area, India

Bengaluru Area, India

To conduct theory and practical classes for Pharm D and post graduate students. To guide the students in their project work and other clinical activities. Establishing and carrying out pharmacovigilance related activities in M.S. Ramaiah teaching and memorial hospital.

Bangaon Area, India

• Involved in post marketing surveillance involving meticulous processing of patient reports received from the countries where the company holds MAH and study sites by abiding the standard operating procedures (SOP).• Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory maintaining the confidentiality of the patient details.• Involves important decision making for entering the case in to the data base… Show more • Involved in post marketing surveillance involving meticulous processing of patient reports received from the countries where the company holds MAH and study sites by abiding the standard operating procedures (SOP).• Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory maintaining the confidentiality of the patient details.• Involves important decision making for entering the case in to the data base, processing the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDDRA, labeling the events according to the Company Core Data Sheet.• Have been a part of the core team that is involved in the initial assessment of the cases before being entered in the database.• Responsible for the receipt, tracking and initialization of single case drug safety reports in to the safety database; accurate data entry and coding of adverse event reports and evaluation of reports within well-defined timeframes, in compliance with the regulatory timeline of respective countries to which the case belongs. Show less

Bengaluru Area, India

• Triage of incoming cases to determine seriousness for prioritization of daily workflow• Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative, assess expectedness of adverse events and code approval numbers Complete quality review of own or peer DSA case executing literature searches to identify adverse events for inclusion in the worldwide safety database.• Working as a team for reporting of spontaneous, solicited… Show more • Triage of incoming cases to determine seriousness for prioritization of daily workflow• Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative, assess expectedness of adverse events and code approval numbers Complete quality review of own or peer DSA case executing literature searches to identify adverse events for inclusion in the worldwide safety database.• Working as a team for reporting of spontaneous, solicited, clinical trial and literature, serious and non-serious individual case safety reports (ICSRs).• Significant experience in case registry, triage, case processing and quality reviewing of ICSRs.• Writing and review of safety narrative and pharmacovigilance control documents.• Participate in customer meetings and keep knowledge of new product transfers. Show less

Master’S Degree, Masters In Pharmacy Department Of Pharmacy Practice

Bachelor’S Degree, Bachelors Of Pharmacy

Education record