MOHAN ELANGO

** ******** ********, ***********, *******, M1G 2M2

E-mail: acqxvb@r.postjobfree.com Tel: 416-***-**** Mobile: 647-***-****

AREAS OF EXPERTISE

Excelled in collecting, assessing and reporting serious adverse events (SAE’s) of Individual case reports (ICSR’s) received for post marketed products from various sources like spontaneous, regulatory, literature and solicited reports

Expertise in collecting, assessing and reporting serious adverse drug reactions (ADR’s) & serious adverse events (SAE’s) from Phase I, Phase II and Phase III of clinical trials

Expert in case processing and writing narratives for Individual case reports (ICSR’s) both domestic and foreign case reports

Expert in assessing the serious adverse events for Medical devices (MDC) Class II and Class II

Managed regulatory submissions of Individual case reports (ICSR’s) for marketed products and clinical trials Phase I, II and III to Health (MHPD &TPD) Canada

Expert in writing drug safety update reports (DSUR’s) for Clinical trials and submitted reports within the timeline from the data lock point

Developed Risk management program (RMP) for marketed products and implemented the RMP on Company Core data sheets (CCDS)

Expert in writing Work Instructions (WI) and Standard operating procedures (SOP’s) for the Clinical trials Phase I,II and III and for the post-marketed products

Highly proven leadership skills for managing multiple projects and successfully completing the projects within the deadline

Exceptional organizational skills that includes problem solving, conflict resolution and analytical skills

Strong verbal and written communications skills to influence the research and presentation of research to clients and committees

Experience in writing contractual agreements for sponsors, vendors and third parties

Expertise in US FDA regulations and Health Canada MHPD regulations for marketed products case reports submission

Bilingual with fluency in writing and reading knowledge in French

Highly skilled in data bases used in marketed products and Clinical trials -Oracle 4.5 AERS, ARGUS 7.0, Docubridge, Clintrace 2.8, Electronic data capture (EDC), and remote data capture (RDC)

PROFESSIONAL EXPERIENCE

Drug Safety-Risk Management Specialist: Johnson and Johnson Inc., Markham, Nov-2013-Present (Contract Position)

Processing domestic adverse reactions and events ADR’s/AEs in RSS (GMS products) in compliance with J&J Global Policies and SOPs. Obtain complete full case information by actively performing follow-ups with consumers and HCPs, as appropriate

Processing foreign adverse reactions and events ADR’s/AEs (MDC products) in compliance with J&J Global Policies and SOPs. Performed follow-ups with consumers and HCPs, as requested by MDC

Planning, preparing, delivering and maintaining Risk Management Plans (RMPs) in compliance with Health Canada requirements and in alignment with the company’s business objectives

Developing proposals for post-market surveillance activities including observational studies and surveys of patients or healthcare professionals to monitor the risks associated with drug products marketed in Canada

Developed periodic safety reports (PSUR) and Canadian annual summary reports (CAR) for consumer products marketed by Johnson and Johnson Canada

Managed regulatory submission of the periodic safety reports and Canadian annual reports

Managed signal detection and evaluation of the signal issues for RMP

Evaluated the Company Core Data Sheet (CCDS), which is the reference Safety information for the consumer products and updated the adverse events sections and warning section present in the CCDS

Prepared contracts for business partner agreements, vendors and third parties for safety data exchange

Liaised with clients, third part vendors and other departments in regards to the case reports and completed the case quality

Liaised with product quality control department in regards to issues and queries raised by consumers and other health care professional for timely reply

Global Pharmacovigilance: Apotex Inc., Toronto, Canada Nov- 2011-Oct-2013

Lead the team for assessing and submitting SUSAR reports from Clinical trials Phase I and Phase III (Oncology trials for Biologics) to the regulatory authorities and Ethics committee

Lead the team for quality check and medical review of Individual case reports (ICSR’s) for the SUSAR’S received from clinical trials

Lead the team for quality compliance related to the accuracy, consistency and data reconciliation for the SAE’s and SAR’s from clinical trials

Processed domestic and foreign individual case reports (ICSR’s) for marketed products and submitted the case reports to MHPD, US-FDA and EMEA agencies; as per the regulatory guidelines

Written narratives for Serious and Non-serious domestic and foreign case reports

Timely follow up with Health care professionals, consumers and third party vendors for the adverse events reported and queries regarding the adverse events

Managed quality review on serious (SAE’s) and non-serious adverse events (AE) and assessed seriousness, expectedness of ICSR's from all sources for post-marketing spontaneous, literature, regulatory and Non-interventional study reports

Presented the safety issues to the drug safety committee and updated the core safety data profile for the marketed products

Lead the team for writing work instructions (WI) and Standard operating procedures for clinical trials

Drug Safety Data Manager: Clinigene CRO, Bangalore, India Feb-2010-Aug 2010

Managed quality control on database according to regulatory guidelines

Managed and integrated all query responses into clinical databases

Managed compile data and generated summary reports for the clinical trials

Provided efficient support to team and evaluated all data collection activities

Clinical Research Associate II: MGMC&RI, Pondicherry, India March-2008-Nov-2009

Designed and managed the preparation of protocols, Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial

Monitored all trial related activities by establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion

Managed informed consent (IC) procedures and protocol requirements are adhered to according to the Clinical trial protocol

Managed the Case Report Forms (CRFs) or other data collection forms are collected in time and verified the Source document against the Clinical trial protocol and monitored the data for missing or implausible data

Recruited and trained the principal investigator, staff nurse and others involved in the clinical study, translated study-related documentation and organized meetings

Drug Safety Associate: PPD Global Inc. LTD, United Kingdom Jan-2007- March-2008

Medically reviewed the serious adverse events (SAE’s) of the clinical trials and reported the serious adverse events (SUSAR’s) for Phase II and Phase III of clinical trials

Managed, organised and compiled the serious adverse events (SAE’s) of the clinical trials and reported the serious adverse events (SUSAR’s) for Phase II and Phase III of clinical trials

Managed regulatory submission of DSUR reports from clinical trials to the UK regulatory authorities(MHRA) and European regulators(EMEA)

Clinical Research Associate CRA I: A.V.M.C &RI, Pondicherry, India May-2001-Aug-2005

Developed and written Clinical trial protocols for Phase I & IIa and Phase IIb and submitted the protocols to Ethics Committee (EC), and Institutional review Board ( IRB) for approval

Designed and developed case report forms (CRFs) depending on the study type

Liaised with the Ethics Committee (EC), and Institutional review Board ( IRB) for the approval and process of the Clinical trial application (CTA)

Identified and assessed the suitability of site facilities to be used as the clinical study site

Trained principal investigator, staff nurse and laboratory technician who are responsible for the conduct of the trial

Verified that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)

Collected the Serious Adverse Event (SAE) from study sites, processed the SAE forms and submitted the forms to the sponsors on time

EDUCATION

MSc -Master’s Degree in Pharmacology, SHU, United Kingdom 2006

MSc- Master’s in Physiology, University of Madras, India 2001

Registration

Registered Physiologist and Pharmacologist: Tamilnadu Pharmacology Association Council, Chennai, India

Awards:

Best employee of the year 2013 from Apotex Inc.,

References available on request

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