Post Job Free

Resume

Sign in

Data Entry Safety Specialist

Location:
Calgary, AB, Canada
Posted:
February 20, 2023

Contact this candidate

Resume:

Priyanka Bhokare

Address SW, Calgary, Alberta, Canada

Phone 403-***-****

Email advgnb@r.postjobfree.com

Professional Summary

To obtain a position where I can utilize skills in safety and regulatory compliance. Strong planner and problem solver who readily adapts to change, works independently and exceeds expectations. Work Experience

03/2022-09/2022

Maternity Break

03/2021-02/2022

IQVIA Canada

Operations Specialist

• Maintains high compliance standards with respect to reporting timelines and quality of local adverse drug reactions (ADR) data

• Keeps up-to-date regarding Canadian and international regulatory developments in the Pharmacovigilance area

• Collects and processes adverse drug reactions from all sources

• Submits all reportable cases according to local legislation

• Initiates and conducts follow-up activities related to local ADR reports

• Assists with regular reconciliation of ADR cases 11/2019 – 05/2021

Walmart Canada

Pharmacy Assistant

• Performing Computer Functions as directed by the Pharmacist i.e. Data Entry; Price Check; Patient Information Entry/Update.

• Filling prescriptions (always under the Pharmacist’s supervision), selecting appropriate products, performing the accuracy program

• Maintaining Inventory Control, assisting Pharmacist in maintaining appropriate stock levels of drugs and supplies, checking for and pulling expired medications at least monthly

• Clerical Organization, filing prescriptions, invoices, reports, correspondence and memos and completing any administrative support functions assigned (i.e. journals, accounts receivable, Aged Trial Balance).

• Assisting with OTC Operations and ordering, stocking, cashier duties as assigned by OTC Manager and/or Pharmacist.

09/2015 – 05/2019

Cognizant Technology Solutions

Drug Safety Specialist (Takeda Pharmaceuticals)

• Manage AE/PV inbox and conduct follow ups as required.

• Perform case processing into global safety database (ARGUS).

• Retrieve source emails and source documents, create CIOMS, submission with partner company.

• Assist with collection, processing, quality check and reporting/submission of Safety events (initial and follow-up) as per the program and department requirements.

• Narrative writing for clinical trial cases

• Assisting with MedDRA coding system

• Conduct follow-ups for information from initial reporter and fill in gaps as necessary.

• Assist in collecting all the information required for CAPA for quality deviations.

• Support with reconciliation activities as per the program requirements.

• Support to conduct activities related to source data verification as per the program requirements and/or PV agreement.

• Provide and support medical information services and participates in coverage after business hours, as required.

• Use available resources and FAQs to provide accurate and timely responses (verbal and/or written) to medical information queries.

• Handles, identifies and obtains pertinent data, and forwards adverse events (AEs), product quality complaints (PQCs) and medical information (MI) inquiries as per the policy and procedures.

• Support with audits as needed.

• Build excellent rapport with the internal and external customers Education

07/2013 – 08/2015

University of Pune

Master of Pharmacy

Course work: Modern Pharmaceutical Analytical Techniques, Drug Delivery System, Modern Pharmaceutics, Regulatory Affair, Molecular Pharmaceutics, Advanced Biopharmaceutics & Pharmacokinetics, Cosmetic and Cosmeceuticals, Biostatistics Project: Design and Characterization of Nanocrystals Research paper publication: Design and Characterization of Nanocrystals of Tadalafil for Solubility and Dissolution Rate Enhancement. Inventi Rapid: Pharmaceutical Process Development, 2015(3):1-7, 2015.

07/2010 - 06/2013

University of Pune

Bachelor in Pharmacy

Course work: Human Anatomy and Physiology, Pharmaceutical Analysis, Pharmaceutics, Pharmaceutical Inorganic Chemistry, Computer Applications and biostatics, Pharmaceutical Microbiology, Pharmaceutical Engineering, Pharmaceutical Organic chemistry, Physical Pharmaceutics, Medicinal Chemistry, Industrial Pharmacy, Pharmacology, Pharmacognosy and Phytochemistry, Pharmaceutical Jurisprudence, Pharmacy Practice, Novel Drug Delivery System, Cosmetic Science

Project: Review and literature on Rheumatoid arthritis. Additional Skills

• Excellent organizational skillsand ability to prioritize

• Critical thinking and decision making skills

• Proficient in Oracle ARGUS safety database, Medidata Rave

• Manual Narrative writing

• Prioritization and organization of workflow activities in a team environment

• General working knowledge of document management systems

• Excellent communication and writing skills

• Ability to work in a team environment

• Excellent problem-solving abilities

• Ability to work within tight deadlines

• Excellent knowledge of medical terminology

• Proficient in computer skills like Microsoft Office Word, Excel, PowerPoint and Outlook

• PowerPoint and Outlook

• Knowledge of ICH, CIOMS and

• Good Pharmacovigilance Practices, Knowledge of drug development process.

• Knowledge of effective clinical data management practices.

• Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

Powered by TCPDF (www.tcpdf.org)



Contact this candidate