Vikram Rao, Md, Bcmas Email & Phone Number

Hamilton, On, Ca

Canada

Canada

Mississauga, Ontario, Canada

Mississauga

Bangalore

• To be responsible for immediate reporting to the relevant authorities of serious adverse events that may be associated with company products.• To be responsible for the medical review of reports concerning serious adverse events, as well as for the evaluation of possible causal relationships.• To ensure the preparation of relevant follow up questions.• To ensure consistency in handling clinical and post-marketing cases.• To escalate critical adverse events/reactions to line… Show more • To be responsible for immediate reporting to the relevant authorities of serious adverse events that may be associated with company products.• To be responsible for the medical review of reports concerning serious adverse events, as well as for the evaluation of possible causal relationships.• To ensure the preparation of relevant follow up questions.• To ensure consistency in handling clinical and post-marketing cases.• To escalate critical adverse events/reactions to line manager and/or Safety Surveillance Advisor.• Monthly review of spontaneous non-serious cases as non-serious line listings to ensure consistency in coding and listedness.• To participate in clinical project groups as well as safety meetings as needed and to ensure responsible coverage of safety areas.• To participate in safety meetings as needed and to ensure responsible coverage of safety areas with the support of a safety operations advisor.• To review clinical protocols to ensure that all relevant safety information is captured through the procedures described in the protocol and to ensure that these procedures are in alignment with the workflow in Safety Operations.• Point of contact providing support for Data Management colleagues if/when product queries arise.• To ensure accurate and consistent coding using MedDRA of all adverse events reported to the company to ensure consistency and precision between projects, products and countries in the coding of adverse events.• To review processes and give input regarding safety information handling and flow of safety information.• To ensure up-to-date knowledge through participation in relevant courses and meetings and through reading relevant literature, regulatory guidelines and new media.• To supervise reconciliation process of SAEs with the clinical trial data base. Show less

India

• Perform single case medical assessment including the determination of seriousness, expectedness/listedness/labeling and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions• Prepare and perform medical review for the safety sections of the aggregate report.• Ensuring the Periodic Safety Update Report (PSUR)… Show more • Perform single case medical assessment including the determination of seriousness, expectedness/listedness/labeling and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions• Prepare and perform medical review for the safety sections of the aggregate report.• Ensuring the Periodic Safety Update Report (PSUR) is medically relevant, complete, consistent and accurate.• Causality assessment and writing medical assessment comment.• Review and finalize narratives.• Actively participates in Kick-off-Meeting (KOM), project planning/strategy making meeting.• Ensuring that the safety issues are adequately addressed in the aggregate document.• Ensure that all the Health Authority (HA) comments from previous PSUR assessment report are adequately addressed in the current PSUR.• To discuss and provide analysis for current review period and cumulatively, including adverse drug reactions reported spontaneously and published literatures.• To review and provide any noteworthy cases for the current review period.• Review the late breaking Argus information, discuss with client medic and address in the document as appropriate.• To review and provide medical comments for published studies including pregnancy registries.• To discuss and provide analysis for drug interactions, overdose, drug abuse/misuse, pregnancy/lactation, special patient groups and medication errors.• To provide the final conclusion regarding the current safety profile of the product.• Responding to medical queries raised by the client Single Point of Contact (SPOC)/Pharmacovigilance Expert (PVE)/Pharmacovigilance Leader (PVL/ Brand Safety Lead (BSL) and provides feedbacks.• Reporting to the Manager on report status and any escalations Show less

Manipal

• Head of Clinical Pharmacogical Unit• Extensive research experience – involved in more than 50 BA/BE research studies. • Conducting studies in a manner consistent with the appropriate SOP's, regulatory guidelines and GCP requirements. • Responsible for the screening of clinical volunteers/subjects• Reviews study information prior to start of screening. • Assess volunteer suitability for entrance into studies. • Review clinical protocol and ICF… Show more • Head of Clinical Pharmacogical Unit• Extensive research experience – involved in more than 50 BA/BE research studies. • Conducting studies in a manner consistent with the appropriate SOP's, regulatory guidelines and GCP requirements. • Responsible for the screening of clinical volunteers/subjects• Reviews study information prior to start of screening. • Assess volunteer suitability for entrance into studies. • Review clinical protocol and ICF prior to commencement of study. • Review subject eligibility to verify protocol requirements. • Confirm Informed consent is given prior to entry into study. • Assess subjects adverse events and provides appropriate medical follow up. • Withdraw subjects as necessary to protect subject safety. • Discharge subjects from the study site. • Review applicable clinical reports as required. • Management of medical emergencies. • Assist with training of medical personnel. • Assist in the creation, development and revision of Standard Operating Procedures. Show less

Mangalore

 Planning and conducting lecture, practical demonstration and tutorial classes for students of medical and allied disciplines. Presenting seminars and reviewing journals on various topics. Carried out Screening of drugs for pharmacological and toxicological profile. Chemical Pharmacology Exercises Experimental Pharmacology including Bioassay Developing expertise in handling laboratory animals. Critical appraisal of promotional drug literature. Critically… Show more  Planning and conducting lecture, practical demonstration and tutorial classes for students of medical and allied disciplines. Presenting seminars and reviewing journals on various topics. Carried out Screening of drugs for pharmacological and toxicological profile. Chemical Pharmacology Exercises Experimental Pharmacology including Bioassay Developing expertise in handling laboratory animals. Critical appraisal of promotional drug literature. Critically reviewing and commenting on research papers. Knowledge about working of Institutional ethics committee (IEC) & Animal ethics committee(AEC), Schedule Y, Drug utilization studies, Case record form, Informed consent process and Patient information sheet Show less

Mangalore Area, India

• Conducting studies in a manner consistent with the appropriate SOP's, regulatory guidelines and GCP requirements. • Responsible for the screening of clinical volunteers/subjects. • Review study information prior to start of screening. • Assess volunteer suitability for entrance into studies. • Review clinical protocol and ICF prior to commencement of study. • Review subject eligibility to verify protocol requirements. • Confirm Informed consent is given prior to… Show more • Conducting studies in a manner consistent with the appropriate SOP's, regulatory guidelines and GCP requirements. • Responsible for the screening of clinical volunteers/subjects. • Review study information prior to start of screening. • Assess volunteer suitability for entrance into studies. • Review clinical protocol and ICF prior to commencement of study. • Review subject eligibility to verify protocol requirements. • Confirm Informed consent is given prior to entry into study. • Assess subjects adverse events and provides appropriate medical follow up. • Withdraw subjects as necessary to protect subject safety. • Discharge subjects from the study site. • Review applicable clinical reports as required. • Management of medical emergencies. • Assist with training of medical personnel. Show less

Mangalore Area, India

• Treating emergency cases like poisoning, Road traffic accidents, acute asthma cases.• Treating inpatients and outpatients.• Attending all types of medico legal cases

Certification, Medical Affairs

Activities and Societies: Medical Affairs

Doctor Of Medicine (Md), Pharmacology

Equivalent to 3 years of graduate medical education, as determined by World Education Services in Toronto, ON

Bachelor Of Medicine, Bachelor Of Surgery (Mbbs), Medicine

Equivalent to first professional degree in Medicine, as determined by World Education Services in Toronto, ON

Education record