Dharmender Singh Email & Phone Number

Laval, Quebec, Canada

• Autonomously and effectively facilitates the organization of study-related required support, including the coordination for both non-GLP studies and GLP studies from study initiation to finalization, via communications with internal departments and external clients, with continued attention to detail and consistency. The Study Director will be consulted with, as necessary, and duly copied/kept informed of all exchanges. • Consults independently with the Sponsor, peers, and other key individuals during protocol development to optimize the protocol design and is responsible for the preparation of protocols and/or amendments/amended protocols. Assures the current copies of approved protocol and/or amendments/amended protocols are available to all study personnel and Sponsors.• Responds, or accurately investigates for the Study Director’s response, to inquiries from internal and external study personnel regarding scientific and/or logistical (scheduling) aspects of the study.• Schedules and/or helps conduct protocol review meetings with Study Director guidance.• Assures schedule changes are captured and communicated as a result of protocol amendments/amended protocols, as necessary.• Drafts and edits project review forms.• Involved with planning and hosting of client visits.• Responsible for review of the raw data throughout the life of a study for clerical/technical errors, thoroughness and consistency, and adherence to SOPs and protocol specifications, and compliance with Good Laboratory Practices (GLPs), as appropriate. Assures coordination for any correction of raw data with appropriate staff. Assures any deviation or unforeseen circumstance that may affect the quality and integrity of the study was reported to the Study Director and addressed in a timely manner.

Montreal, Quebec, Canada

• Lead the finalization process for several reports by providing support to the assigned Study Director(s)• Coordinate and collaborate with involved internal Scientists, Principal Investigators, and/or Sponsor to produce quality, on-time final reports• Autonomously (until the Study Director’s involvement is required) manages the receipt, distribution, pursue of, and/or address of report comments with scientific judgment and accuracy• Ensure completion/availability of all required documents and notifications in support of report finalizations• Prioritize workload to manage the concomitant finalization process of multiple reports• Communicate effectively and own the ability to adhere to timelines for successful finalization of studies• Assists with management of Quality Assurance (QA) audits, answers QA audit findings and assures necessary corrections• Participate and execute various ongoing automation projects to the improve communication within organization, schedule adherence, transparency, and progress monitoring

Montreal, Canada Area

• Collecting data on Safety Pharmacology studies including: Cardiovascular (Telemetry), Respiration and Nervous system• Performing atmosphere generations on Inhalation studies and collect atmosphere sample for the determination of atmosphere concentration and particles sizes. Also measure atmosphere condition for determination of temperature, humidity and oxygen level.• Performing Electrocardiograms (ECG’s), Blood pressures (BPs), biological sample collection (blood, urine), surgery or other technical procedures as needed• Uses, maintains and calibrates procedure related equipment• Signs and dates study schedule of events for confirmation of performance

Montreal, Canada Area

• Literature search: Used Ovid, Medline and other search engines to perform qualitative literature searches and systematic reviews of literature, develops literature search strategies (PICO, reproducible queries, etc.) and extracts data for inclusion in meta-analyses.• Medical writing: Gathers multiple sources of clinical and economic evidence, summarizes findings exercising a balanced point of view and adjusts writing style to audience. Uses appropriate reference sources in Harvard reporting style to submit to conferences and peer-reviewed journals.• Meeting organization: Organizes meetings and web-conferences, with external and internal clients (i.e. advisory panel of key experts), among others, communicates to experts and their assistants in a professional and compelling way and exerts judgment in timing of follow-ups.• Methodology development: Identifies resources, develops methodologies to best answer the research question(s) by anticipating the advantages and disadvantages of each.Modeling: Develops and/or adapts economic model

Saudi Arabia

1) Maintains alertness on opportunities for service enhancement; endeavors to continually improve quality work.2) Research and provides drug information to answer inquiries related to medications, such as Dose, New Drug, Pharmacokinetic Profile, Drug Interaction, Identification, Compatibility, ADR/Contraindication, Stability, Availability, Efficacy and Cost.3) Monitoring activities in the Pharmacy department i.e. antibiotic surveillance, cost-effectiveness of drug usage in the hospital, compliance of the different departments in the implemented Pharmacy department policies and procedures.4) Revising and preparing new Policy & Procedures and Medication error monitoring.5) Creation of Medication Safety Program in support of the Patient Safety goal of the hospital. Implementation of Drug-Food interactions in Unit-Dose labelling for In- Patients.6) Drug-Drug and Drug- Food interactions monitoring.7) Performs market research.8) Maintains confidentiality of files, reports, records and relevant information.9) Reviews and evaluates requirements submitted by pharmaceutical companies for inclusion to the formulary.10) Issues Formulary Request form to corresponding department chair/ section chief for drugs to be included in the formulary.11) Analyze and provides information of drugs for approval of the Therapeutics and Medication Safety Committee, for formulary inclusion.12) Assists in updating the Hospital Drug Formulary.13) Coordinates with Marketing Department for production of Formulary Handbook.

Bangalore Area, India

1. Perform all required activities to ensure appropriate support of monitoring of investigator sites and trial execution.2. Point of contact for sites and facilitator of communication between sites and key Biocon line functions.3. Ensure preparation, collection and distribution of trial master file documents and maintenance of investigator file.4. Timely write-up of study monitoring visit reports.5. Set-up and ensure maintenance of investigator site file.6. Manage site medication supply and sample management during course of study.7. Support more experienced colleagues and investigator in implementing appropriate contingency plans as needed.8. Support more experienced colleagues in ensuring continual compliance with GCP, ICH and Biocon SOPs in informed consent process, source data verification, AE and SAE reporting, protocol execution, drug accountability, and other tasks as specified. 9. Escalate any issues regarding study conduct to manager as needed

Master'S Degree, Epidemiology, A-

Activities and Societies: • International Society For Pharmacoeconomic and Outcomes Research (ISPOR) • The Canadian Association for Health.

Master'S Degree, Pharmacology And Toxicology, A+

Activities and Societies: PK/PD Studies, Uses of HPLC, NMR, UV/ and other instruments. Learned to do Jugular vein Canulation, withdrawing.

Bachelor'S Degree, Pharmaceutical Sciences, First Grade

Activities and Societies: Community Pharmacy Monitoring