7626962110

anika9014@gmail.com
ANIKA SHARMA
Drug Safety Associate II
linkedin.com/in/anika-sharma1

PROFESSIONAL SUMMARY
More than four years of experience in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies,
solicited programs and literature articles) which include triage, registration, duplicate search, data entry, Quality control, data validation of
ICSRs and submission activities. Trained and mentored Drug Safety Associates in various activities of case processing.

PROFESSIONAL EXPERIENCE
Drug safety associate II, Parexel International Services India, Mohali (April 20222- Present)
Drug safety associate I, Parexel International Services India, Chandigarh (July 2020- March-2022)
Drug safety associate, Parexel International Services India, Chandigarh (Feb 2019- June-2020)

 Pharmacovigilance/ Drug Safety experience

(Book-in, triage, evaluation, data entry, quality control, submission/transmission)
 Monitoring of incoming reports from various sources viz mailboxes, Eudra-Vigilance, E2B gateway, LAM etc.
 Experienced in handling drug and medical device reports
 Triage of incoming reports for completeness, legibility, and validity, including literature abstracts/articles
 Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be
submitted to the regulatory authorities
 Creation of the case on the safety database
 Experienced in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider
 Experienced in management of ICSRs of all case types (Literature and non-literature: spontaneous, solicited programs, and
clinical studies)
 Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling
documents (such as Summary of Product Characteristics (SPC), Core Data Sheet (CDS), Investigator's Brochure (IB) etc.), writing
case summaries, assessing causalities if required
 Experienced in maintaining a good working knowledge of the adverse event (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.
 Performs Quality checks/validation checks: management of ICSRs of all case types (Literature and non-literature: spontaneous,
solicited programs, and clinical studies)
 Experienced in submission/ transmission activities
 Handling other activities related to case processing as requested/assigned by the client, including but not limited to performing self-
identified or requested case corrections or performing deletion/deactivation requests as per client conventions and guidelines or
performing coding and recoding of Study, Protocol ID, Suspect, Product, Concomitant, Treatment or Adverse Event or Other MAH
reporting or Safety notification or Patient Oriented Program (POP) or social media (SM) related activities (as applicable)
 Experienced in maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance
with internal and regulatory timelines for adverse event reporting

 Query management
 Assigned subject matter expert (SME) for the team: Experienced in handling team queries
 Experienced in interacting with client personnel to resolve issues related to the processing of ICSRs in accordance with clients’
policies
 Experienced in responding to clients/customers in a timely manner
 Observant in identifying clinically relevant information missing from case report and facilitate its collection via follow up s

 Project Training and mentoring experience

 Client certified trainer: Delivering client specific trainings to the new team members
 Training and mentoring new team members on case processing of ICSRs involving triage, evaluation, data entry, quality control
and other tools related to case processing.
 External and internal audits
 Have been a part of 2 quality assurance audits as a presenter of ICSR process
 Worked on creating Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans

PHARMACOVIGILANCE TRAINEE
Academy of Clinical Intelligence Aug 2018 - Jan 2019
Practical hands-on experience regarding case processing on HAROM safety suit 1.0.1 including initial case entry, duplicity
check, and complete case entries.
Experience in the case review process applying a high standard of quality review to ensure sound medical safety data
documentation.
Knowledge of Case Triage, Case Narrative writing, performing Labelling/ Listedness, and Causality
determination. Understanding of Drug Development Process including Drug safety and different Phases of
Clinical Trials.
Detailed knowledge of ICH guidelines including a basic understanding of regulatory requirements for Pharmacovigilance.
Detailed knowledge of the clinical trial process.

TECHNICAL SKILLS
Tableau, medical dictionary: MedDRA v26.0
MS Office: MS Word, MS Excel, MS PowerPoint
Database: ARGUS, AEGIS, HAROM Safety 1.0.1

TRAINING AND CERTIFICATION

 Successfully completed a technical training program on Pharmacovigilance with quality case processing from the Academy
of clinical Intelligence (a Pharmacovigilance Training Management Company), Chandigarh
 Certificate course in Drug Regulatory Affairs (DRA) from Udemy
 Medical writing skills for beginners from Udemy
 Writing in the Sciences- ongoing from Stanford university

EDUCATION
Post-Graduation in Microbial biotechnology Jul 2016- Jun 2018
S.G.G.S College, Panjab University Chandigarh, India
Microbial Biotechnology

Under Graduation in Industrial Microbiology Jul 2013- Jun 2016

G.G.D.S.D college, Panjab University Chandigarh, India
Industrial Microbiology, Zoology, chemistry
Jul 2011-Mar 2013
High School
Chandigarh, India
G.G.M.S.S, Chandigarh
Physics, Chemistry, Biology Apr 2006- Mar 2010
Secondary School Chandigarh, India
Ryan International School

PROJECT
Extraction and in-vitro evaluation of antitumor activity of bioactive constituents from vegetable and fruit waste.

ADDITIONAL INFORMATION
Languages: English, Hindi, Punjabi, German (A1)