Safety Data Analyst

Dr. MOHAMMAD JUNAID MEMON

** *** *****, ****** *****, Jersey city, NJ 07306 ● 201-***-**** ● **********@*****.***

PROFESSIONAL SUMMARY:

5+ years of work experience in Drug Safety/Pharmacovigilance industry including both clinical and post marketed drugs

Performed Quality Review of Clinical Trial cases, Individual Case Safety Reports (ICSRs) and Literature cases

Manage Triage team and Case allocation on daily basis and maintenance of global drug safety trackers and mailboxes

Act as operational nexus for inter- and intra-departmental groups to coordinate, organize, track, and complete activities in support of signal detection and risk management

Use strong project and organizational knowledge, leadership, and active facilitation to proactively enable effective team meetings and high performance teams

Functional knowledge of aggregate reports including PSURs/PBRERs, PADER, Ad Hocs, Clinical trials protocol, Informed Consent and Investigator Brochure

Managed Safety database transition activities from its early inception till execution and making it operational in minimal time (transition from one safety database to another).

Functional knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including - ICH guidelines on safety and efficacy - New PV legislation, GVP modules, CIOMS, GMP, GLP, IND, NDA, CTD, 510 (K)

Expertise in Case validation, MedDRA coding, WHO drug coding, generating and updating narratives ensuring quality, detail, clarity and consistency according to CIOMS template and Company’s Standard Operating Procedures as applicable

Experience in performing Quality review of Adverse Events, Serious Adverse Events based on approved case processing metrics

Excellent understanding of investigations, review, monitoring of Root cause analysis (RCA) and corrective and preventive actions (CAPA) relating to non-compliance issues and findings.

Proficient in global safety data bases (ARGUS, AERS, RSS, ARISg, SCEPTRE) along with high level working skills in Microsoft Office (Word/Excel/PowerPoint)

Excellent managerial and communicational skills, zest to excel and perform beyond expectations

Tuned to manage both time and priority constraints and to manage multiple priorities simultaneously

EDUCATIONAL QUALIFICATIONS:

PACEUNIVERSITY, New York, NY May 2016

Master of Business Administration in Strategic Management, GPA: 3.78

INSTITUTE OF CLINICAL RESEARCH INDIA (ICRI), Mumbai, India January 2010 Post-Graduation Diploma in Clinical Research (1 year), GPA: 3.7

Smt. C.M.P. HOMOEOPATHIC MEDICAL COLLEGE, Mumbai, India December 2009 Bachelor of Homoeopathic Medicine & Surgery, GPA: 3.88

CERTIFICATIONS:

Project Management Institute

Certified Associate in Project Management (CAPM) - Currently pursuing (Aug-2016)

GRADUATE ACADEMIC ACHEIVEMENTS:

Nominations by the Graduate advisement department at Pace University for Lubin Outstanding Student Award & Lubin Graduate Leadership award

Honor Society Memberships:

Lifetime membership to Beta Gamma Sigma International Honor society owing to consistent high GPA throughout the MBA program and Leadership qualities. (Membership in Beta Gamma Sigma is the highest recognition a business student anywhere in the world can receive in a business program accredited by AACSB International. Membership is by invitation only and offered to the top 10% students of business schools around the world)

PHARMACOVIGILANCE EXPERIENCE:

Johnson & Johnson (Contractor), Skillman, NJ 06/2014 - Present

PV Data Analyst

Responsibilities:

Manage the adverse events follow up process for a Top 5 brand pharmaceutical client

Prepare reports and metrics for audit, inspection and internal purposes for the process

Act as a point of contact for the client and act as Project coordinator for an operational team of over 200 in US, Manila & India

Manage relationships with clients and internal stakeholders by providing expert safety knowledge

Manage and maintain the Global Drug safety Mailbox and Global Clinical Trial Drug safety Mailbox

Work effectively and closely in a matrix environment with on- and off-site team members to integrate input into operational plans.

Inform all team members and groups of deliverables and timeline, project developments and insuring completion according to timelines.

Contribute to the functional excellence of the department by participation in the development and continuous improvement of processes, procedures, and tools related to Drug Safety

Work with databases to appropriately update information regarding adverse event follow up

Managing complex and time-sensitive special projects, such as ad hoc Regulatory Authority safety queries

Ensuring timely receipt and accurate archiving of documents in support of inspection-readiness

Ensure to work within the SOP system, including departmental Work Instructions (WIs)

SCIFORMIX TECHNOLOGIES PVT. LTD, Mumbai, India

Sr. Safety Data Analyst (Pharmacovigilance/Drug safety) 09/2011 - 10/2013

Responsibilities:

Perform quality review of SAE’s, SUSAR’s and AE’s based on company approved case processing metrics for ICSR’s and Literature cases.

Work Force Manager: keeps track of the work progress and update the workflow with in-house tracking tool.

Point of Contact (POC) for all sorts of queries / meetings (conducted weekly and monthly).

Manage the Triage team, daily Triage process workflow and case allocation.

Perform triage of reports of potential adverse events & check reports for duplication, precision and completeness

In conjunction with the safety physician, proactively assisted in evaluating the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs

Identify and use appropriate sources of information and database searches to retrieve relevant data for identification and evaluation of signals

Assist in developing and revising processes like EU-RMPs, US-REMs and SOPs pertaining to safety issues

Perform case processing of ICSRs in safety database and other case management activities such as check and remove duplicate entries

Summarize all the gathered information about the case into a concise clinical narrative

Select event terms using medical knowledge and assessed expectedness/ listedness of AE and SAE for company products and code for adverse events and drugs using MedDRA and WHO-DD respectively

Formulate and Generate queries for collection of additional information for spontaneous adverse events to ensure accuracy and completeness of the case

Follow-up of serious and non-serious cases in accordance with FDA/ICH regulations

Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities

Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes

Perform Medical review of serious adverse events and write company comment when required

QC of documents for accuracy, formatting documents, collaborate with multidisciplinary teams on product safety-related issues, signal detection templates

Perform SAE reconciliation

Serve as a resource and participated in strategic business development activities including presentations to prospective clients, professional meetings and other business development activities for the company

SCIFORMIX TECHNOLOGIES PVT. LTD, Mumbai, India

Jr. Safety Data Analyst (Pharmacovigilance/Drug safety) 08/2010 - 02/2011

Responsibilities:

Case processing of all case types (spontaneous, clinical studies, literature & MHRA)

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

Initiation of ICSRs into the safety database

Conduct data entry 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 CIOMS comments if required

Conduct data validation i.e. cross checking against source documentation. - Medical review of ICSRs - Data capture of E-receipts cases

Perform Medical review of serious adverse events and write company comment when required

Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”

Experience in data handling and data analysis

Maintain an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting

Perform quality checks of ICSRs to ensure high quality of the safety reports in accordance with the client SOPs and regulatory requirements

Interact with internal or external contracts to resolve issues related to the processing of adverse event reports

Conduct weekly literature review to identify adverse events and evaluate new safety findings from scientific and medical literature

Perform quality review on compliance data

Utilize expertise on AE reporting and analysis to develop/enhance the identification and investigation of causal candidates precipitating root cause

Ensure compliance with FDA regulations, ICH & GCP guidelines to meet Safety and Pharmacovigilance reporting requirement

SCIFORMIX TECHNOLOGIES PVT. LTD, Mumbai, India

Trainee Safety Data Analyst (Pharmacovigilance/Drug safety) 01/2010 - 07/2010

Responsibilities:

Receive and enter adverse drug events, as well as follow-up from vendors, clinical trials, and spontaneous complaints from consumers and healthcare providers into Safety Data Base

Manage data from both post market as well as clinical trials according to specific regulations and guidelines

Conduct initial triaging of cases coming from the US drug safety intake

Review, rank, verify, process and document case-related information: event terms, validity, seriousness, special scenarios, time line accuracy and consistency effectively using both MedDRA coding as well as WHO-DD to report necessary items

Reconcile with all internal and external reporters accurately and promptly

Proficiently write and, where necessary edited the case narratives of each adverse drug event received

Liaise with key partners, locally and other stakeholders regarding safety data collection and data reconciliation

Determine reportability of scheduled reports, always ensuring adherence to regulatory requirements, as well as internal SOPs

CLINICAL EXPERIENCE:

Homoeopathic Physician, Mumbai, India 02/2011 - 10/2013

Communicate with patients to develop a detailed case history

Used medical knowledge to treat a range of conditions e.g. Diabetes, Eczema, and Psoriasis etc with homoeopathic remedies.

Monitored and evaluated patient progress and advised them on lifestyle issues, such as diet, exercise and mental health

Analyze each case to select a remedy appropriate for the individual

Conduct seminars and presentations in the community to promote health awareness and prevention of disease

SKILLS:

Computer: Proficient in Microsoft Word, Microsoft Excel (Macros, Look up function), Solver, StatTools suite, Outlook, AERS database, RSS Safety database, SCEPTRE safety database, ArisG database and Argus safety databases, MedDRA coding, WHO-DD coding and IRMS database

Language: Fluent in English, Hindi, Marathi and Gujarati

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