pratik1996
About me
I have 6 years of experiecne and currently on a career break due to health reasons. I have been undergoing treatment and physical therapy for Limb-Girdle Muscular Dystrophy, a condition I have been managing with medical guidance. This period has allowed me to focus on my well-being and long-term health. I am now looking forward to returning to the workforce with renewed energy and commitment.
Work Experience
Junior data analyst
Inventurus knowledge solution
2018-08-20
-
2020-01-31
1.Quality Reviewer.
2. CDH - Data Validation
3. Advocate - Transfer of Medication
4. E- Clinical works - Patient’s information transfer.
Case manager
Tata consultancy services
2020-02-05
-
2021-11-04
1. USDS Affiliate.
1. Wrote narratives summarizing the events according to departmental SOPs.
2. Trained and mentored Peers in case processing methodologies, as per regulation and local SOPs.
3. Ensured compliance by informing senior management of any process gaps with respect to FDA regulations, viz changes in regulations and guidelines for marketed investigational products, and recommended changes where applicable.
4. Trained and mentored new drug safety associates, providing supervision and teaching key
skills in Drug Safety.
5. Handled initial and follow of pharmacovigilance transactions from consumers, health care professionals, and attorneys, as necessary, in accordance with Forest policy and procedure.
6. Assigned and completed expedited cases to ensure regulatory and client deadlines were met.
7. Informed appropriate staff of delayed, missing or incomplete items established follow procedures and completed all transactions in a timely manner. Minimized risk through active collaboration with Quality Standards and interfacing with management as needed.
8. Expertise in safety systems experience and case processing, interfacing with teams formed to assess the continuing safety profile for the compound or product As a Molecule Lead, presented various Presentation to fellow colleagues and made them understand the grey areas, the risk and benefit factor of the particular molecule.
2. France Affiliate.
1. Accountable for performing the appropriate assessments of source document to identify potential adverse event (including the assessment of seriousness for each adverse event) adhering to SOPs other controlled documents and regulatory requirements.
2. Responsible for retrieving and uploading the source documents in IRT to create receipt items for all valid cases with adverse events.
3. Accountable for handling ICSRs received via data exchange systems, disposition of valid items into ARIS from IRT for further processing in ARIS.
4. Performing duplicate searches in IRT with details provided on source document and classifying a report as initial or follow up case.
5. Accountable for sending queries for clarity associated with incoming information if required.
6. Accountable for performing accurate data capture such as reporter, product, patient and adverse event details from source documents. In addition, all minimum fields must be completed in IRT, as per Global: ICSR Safety Receipt System Quality Review Checklist.
7. Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management.
8. Responsible for quality reviewing of cases as per applicable SOPs and process docs.
9. Sharing/receiving the source documents and translated documents with translation vendor team diligently.
10. Responsible for ensuring that the individual training records are updated in line with inspection readiness.
11. Representing team in regulatory and internal inspections and audits as required.
12. Demonstrating knowledge of safety concepts, global regulatory reporting obligations and relevant SOPs.
Pharmacovigilance associate
Apcer life science
2021-11-08
-
2024-08-24
1. Data Entry and Quality Check/Review of safety reports in Global Intake Tool.
2.Establish work priorities and direction under the guidance of the Sr. DSA or the Sr. Manager.
3.Monitor and manage the ICSR workflow for assigned projects and products to ensure all deadlines are met and compliant with safety reporting obligations in accordance with international reporting regulations, SOPs and safety processing guidelines as defined by department management.
4. Perform and/or oversee the collecting, documenting, and processing of adverse event (AE) reports from clinical trials and post marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance. This includes detailed review of source documentation, assessing cases for report ability, accurate data entry, and quality check.
5.Perform and/or supervise follow-up activities with consumers and/or health care professionals.
6. Perform and/or supervise the timely reporting of SAES/AES to Regulatory Authorities, and cross-reporting to other pharmaceutical partner(s) and licensing partners per PVAS. Support case processing as a SME for MedDRA coding.
7. Conduct and/or supervise the periodic reconciliation of safety data between the drug safety database and the clinical trial databases.
8.Conduct and/or supervise the periodic reconciliation of safety report information between the drug safety database and local PV representatives or business partners.
9.Supports management as SME for ICSR handling during pv related regulatory inspection or internal quality assurance/corporate compliance audits.
Education
SSC
CBSE
2001-02-10
-
2012-05-21
10 th standard had been passed from kendrivya vidyalaya I.S.P
HSC
Science
2012-07-17
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2014-06-25
12th standard had been passed from maharashatra state board.
B pharmacy
Pharmacy
2014-08-05
-
2018-06-30
Complted b pharmacy from savitri bai phule university
Disability-Info
UDID
Yes
UDID Number
MH4890519960028233
Upload UDID Card
Upload Disability Certificate
Disability Percentage (As per certificate)
40