Sinojkumar Nair

• Provide technical writing, research support, and benefit-risk analysis for key benefit-risk management (BRM) deliverables, such as Risk Management Plans (RMPs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Evaluation and Mitigation Strategies (REMS), and signal detection reports.
• Authored 30 BR reports (BRA, BRAD, BRAC).
• Authoring approximately 108 PBRERs, approximately 56 DSURs, 35 ACOs, and 6 COs.
• Reviewer for more than 200 inclusive PBRERs and ACOs.
• Authored 25 de novo RMPs, 108 RMP updates, and reviewed nearly 60 RMPs.
• Contribute to the pharmacovigilance and benefit-risk perspectives and content in the writing of RMPs, PBRERs, signal detection reports, and other BRM deliverables using pharmacoepidemiology skills and scientific knowledge.
• Identify, obtain, and synthesize information and data for the creation of BRM deliverables (i.e., search and extraction of key figures from existing documents, in-depth literature reviews, internet searches, descriptive data analysis, etc.).
• Contribute to overall safety knowledge, and methods for routine regulatory submissions, and other related activities.
• Seek and provide in-house training, as necessary, to fulfill responsibilities.

• Worked on 90 signal detections of products, signal validation, and signal evaluation 40.
• Supporting PV activities for a product, or group of products, in partnership with the GSO to evaluate safety data from multiple sources and signals for assigned clients' products.
• Signal management activities.
• Supporting GSO for safety-related activities on assigned clients' products and managing ongoing core signal detection activities for GSO review and authoring periodic signaling reports, conducting preliminary analysis.
• Coordinating, authoring, and proposing responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with GSO.
• Supporting the preparation and maintenance of safety sections of the Company Core Data Sheet. In partnership with the GSO, we are providing strategic input and reviewing applicable sections of the PBRER and DSUR to ensure that aggregate data analysis is consistent with the overall product safety profile.
• Providing safety content for new drug applications and other regulatory support to GSO for benefit-risk sections, preparation, and review of relevant safety sections to ensure consistency across documents, and support response preparation.

• Promoted teamwork within the workplace by encouraging collaboration among staff members on various project tasks.
• Developed strong working relationships with staff, fostering a positive work environment.

Team Leader for aggregate reporting and Submission team

Preparation and review of PSURs and PADERs.

Preparation and review of RMPs

Manage daily workload in conjunction with team for individual case processing, literature searches, and any other tasks relevant to the Pharmacovigilance.

Conducting Telecon or WEBEX with affiliates and service providers for discussions, queries and trainings.

To ensure that all team members are updated with the regulatory guidelines for all region/ countries.

Preparing presentations and presenting as and when required by management.

Manage daily workload in conjunction with team for individual case processing, literature searches, and any other tasks relevant to the pharmacovigilance.

Quality check of ICSRs.

Trained on literature surveys, reviewing, assessing and decision making for reportability by looking for positive attribution in the literature article.

Submission of ICSRs like 15-day reports, PSURs and PADERS.

Data Entry and Quality Check of ICSRs in pharmacovigilance database (ARGUS) and other case management activities

Follow-up of serious and non-serious cases post marketing surveillance involving meticulous processing of patient reports received from the client’s trial sites and marketed 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 to avoid reporting of the incorrect data and by 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 MEDRA, labeling the events according to the provided labeling documents Company (Core Data Sheet, Summary of product information, investigator brochures etc.).

Have been a part of the core team that is involved in the initial assessment of the cases before being entered in the database.

Trained on literature surveys, reviewing, assessing and decision making for reportability by looking for positive attribution in the literature article.

Triaging and book in of the valid cases.

Performing spontaneous and clinical trial case processing.

Pharmacovigilance department:

Data Entry of ICSRs in pharmacovigilance database (PVnet) and other case management activities

Follow-up of serious and non-serious cases post marketing surveillance involving meticulous processing of patient reports received from the client’s trial sites and marketed by abiding the standard operating procedures (SOP).

Write the narrative in a chronological format and 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 MEDRA, labeling the events according to the provided labeling documents Company (Core Data Sheet, Summary of product information, investigator brochures etc.).

Have been a part of the core team that is involved in the initial assessment of the cases before being entered in the database.

Phase Experience in the Therapeutic Areas like:

Anti-cancer drug : First in man (Phase-I) trial (Dose escalation, Single dose by oral route of administration)

H1N1 Trial (Phase I, II and III)

PD (Parkinson’s disease) drugs: Food effect study

Anti- psychotic drugs:Formulation change study in steady state condition

Anti-obesity drug:Phase-I trial Multi dose, dose ascending by oral route of administration in overweight/obese subjects.

Diabetic drugs:Phase-I trial rising multiple dose, type-II diabetic male subjects

Seasonal Influenza vaccine: Phase I trial to assess safety and immune response of Trivalent, Live Attenuated Seasonal Influenza vaccine

Handled and monitored more than 90 BA/BE trials.

• Conducted clinical trial in accordance with protocol and recorded and monitored progress.
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
• Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.

• Established strong relationships with healthcare professionals, resulting in increased trust and credibility for the organization.
• Analyzed market to identify new opportunities and strengthen relationships with hospitals, medical centers and primary provider physicians.
• Collaborated with sales team to develop targeted marketing strategies that boosted overall revenue growth.
• Managed territory efficiently, effectively prioritizing visits to key healthcare providers and facilities.