Mariya Pattammattel Chacko

***-*** ******** **, *********, Ontario • (1-519-***-**** •adq59m@r.postjobfree.com

PHARMACOVIGILANCE SPECIALIST

Profile

An Innovative Pharmacist with 2 years of experience in Pharmacovigilance (ICSR case processor and Literature Reviewer) with working knowledge in Argus safety database looking for advancement in Pharmacovigilance field.

Energetic professional with high efficiency towards prioritizing ICSRs under the pressure of stringent regulatory timelines in a fast faced environment and ability to build strong positive relationship with other care professionals including clients.

Highlights

●Good Command on ICSR (Individual Case Safety Reporting) management.

●Efficient in Argus Data Base.

●Process the Safety Data based on applicable regulations, guidelines, Standard Operating Procedure,Work Instructions (WI).

●Strong Knowledge of Medical terminologies including MedDRA coding and WHO coding.

●Good Knowledge in ICH GCP Guidelines, GVP, Phase II-IV clinical trials.

●Good Knowledge in US and EU regulations, Health Canada and Pharmacovigilance guidelines.

●Ability to understand Patient safety regulatory obligations.

●Efficient to deliver within the established timelines.

●Good knowledge in Pharmacovigilance terminology.

●Well versed with data conventions for various types of cases (including spontaneous, non-interventional, interventional clinical trial cases and follow ups to the literature cases).

●Experience in Narrative Writing.

●Efficient in Literature Review and to determine the case Validity.

●Technically good knowledge on clinical research, Pharmacovigilance, SUSAR, NON SUSAR, PSUR reports.

●Excellent Project management skills

●Maintaining good communication with the clients.

●Good Knowledge in Microsoft Office, Excel, Power Point, Outlook.

●High degree of Accuracy and ability to meet deadlines.

Relevant Work Experience

Pharmacovigilance Specialist (Tata Consultancy Services, Maharashtra, India (May2021-February2022)

Assessing the Literature cases to identify the validity of the cases

Assessment of Literature reports for seriousness, causality and expectedness.

Literature Search

Assess and evaluate the valid cases from literature article to the Book-in.

Assessing the ADR for its validity and nullifying it with justifications.

Maintain Pharmacovigilance agreement with all vendors as required by the Health authorities.

Junior Drug Safety Associate (Bioclinica India Pvt Limited, Karnataka, India (January 2021- July 2021)

●Responsible for data entry of individual case safety reports into the safety database, medical evaluation of cases, assessment of reportability to health agencies.

●Triage ICSR.

●Reviewing Spontaneous/Post marketing/Clinical trial/Literature case reports concerning serious adverse events in global safety data base according to ICH safety reporting requirements and GVP from various sources (CIOMS,E2B,MedWatch).

●Responsible for writing the narrative as required.

●Preparation of aggregate reports and company comments.

●Responsible for screening of Canada Vigilance adverse reaction data base.

●Risk management plans.

●Submission of documents to the Trial Master File (TMF) and Pharmacovigilance system Master File .

●Signal detection and management.

●Conducts GVP auditing.

●Review and evaluate AE case information to determine validity of case, seriousness and expectedness as per client and internal policies and procedures.

●Responsible for coding all medical history, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (MedDRA, Company product dictionary).

●Initiates follow up activities to obtain additional information and clarification, as appropriate.

●Initiate query action items (split case request and clarification of discrepant case information).

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Clinical Pharmacist Trainee

KMCT HOSPITAL, CALICUT, KERALA, INDIA (Sep 2018 – Sep 2019)

Actively involved in patient care and patient medication dispensing for various departments like Pulmonology, Pediatrics, Orthopedics, Cardiology and General medicine.

Handled patient counselling and device demonstration at patient counselling desk for in patients and outpatients

Took part in ward rounds and pharmacist rounds in various departments.

Proactive involvement to safeguard the use of drug by checking prescription validity, drug interactions and placing of order.

Respond to patient directly and provide patient care service by assisting them to clear medicine related quires as a pharmacist

RESEARCH PROJECT:

Assessment and management of cardiac injury by perioperative rosuvastatin in non-cardiac surgery patients. World Heart Journal; Volume 12; Issue 3;2020

Education

Doctor of Pharmacy August 2013 – September 2019

Kerala University of Health Sciences, Kerala, India

Reference: Available upon request

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