Harsimrat Kaur
**** *** **** ****, *******, TX **063
acwww1@r.postjobfree.com
Job Objective
To obtain a position in a clinical research setting with emphasis in drug safety and pharmacovigilance where my medical background and experience can be higly valuable. Career Summary
Feb 2012 – July 2015 Pharmacovigilance Specialist, Parexel International Services India Private Limited
(Former Quantum Solutions India).
Jul 2011 Feb 2012 Worked as a full time dentist in a private dental setup Education
Year 2006 2011 Bachelors in dental surgery (B.D.S) from National dental college and hospital, Derabassi
(Pb) India.
Summary Skills
Proficiency in initiation and data entry in drug safety database
Remarkable knowledge to monitor and track Serious Adverse Events
Indepth knowledge of US and ICH safety reporting regulations and guidelines
Capability to make concise, accurate ant relevent synopses of medical text and data and abilty to write unambiguous medical text
Good knowledge of medical terminology
Experienced in identifying/formatting/responding to queries
Ability to evaluate and draw conclusions independently
Fluency in written and spoken english
Computer proficiency to work with web based applications and the MS Office suite
(Word/Excel/Powerpoint) and in handling the ERP systems (Enterprise Resource Planning)
Good experience in providing mentorship to team colleagues Professional Knowledge/Work Experience:
Pharmacovigilance experience as PV Scientist
Experienced in management of Individual Case Safety Reports (ICSRs) of all case types
(spontaneous, clinical studies, solicited programmes, serious or non serious and Licensee cases) which includes:
triage of ICSRs to determine whether they qualify for expedited reporting (determine the validity of a report) or not and the timelines within which they need to be submitted to the regulatory authorities
Experienced in
Registration/initiation of ICSRs into the safety database
Conducting duplicate searches prior to registration and identifying potential duplicates
Managing duplicate cases appropriately
Trained in
Coding of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required
Conducting inactivation and deletion of invalid ICSR processing of ICSR's
Data validation i.e. cross checking against source documentation
Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”
Working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including
ICH guidelines on safety and efficacy
Volume 9A
FDA guidelines
CIOMS
Trained in
Global Compliance Monitoring of ICSR’s
Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Served as a Late case reviewer
Assesment and capturing of lateness reasons of the ICSR's associated with the products on worlwide basis on the drug safety database, in accordance with International and local regulatory requirements
Served as a PV Analyst ( formerly titled "Global Compliance Analyst")
Ensuring Compliance of ICSR with company and regulatory requirements
Implementing and maintaining systems, processes, and metrics to monitor quality, performance and compliance of safety activities and deliverables in the key areas of compliance, quality and performance.
Assisting and ensuring corrective and preventative action plans are in place in response to audit or inspection findings, or in response to internally identified trends in errors or other non compliance, in coordination with other Compliance teams and stakeholders.
Sending monthly communications to license partners (LP) and affiliates and collecting lateness and Corrective and Preventive actions (CAPA) for late EMA and FDA submissions