Clinical Research Quality Assurance

NEHA SAHNI (PV OFFICER)

WORK EXPERIENCE

BRIEF BIOGRAPHY

An enthusiastic Drug Safety and Clinical Research Professional with background in science. Experienced as analytical and result-oriented PV professional. AUG 2021 – Present PV OFFICER/ICSR Management PRIMEVIGILANCE USA Inc, NC, USA Providing support to other activities undertaken by the project team on behalf of the client and the company

• Performing activities in the scope of ICSR/post Marketing/ device/ clinical Trails management unit within agreed extent and timeframe (including, but not limited to):

• Hands-on experience in managing the safety mailbox, booking, triaging, and distributing Individual Case Safety Reports (ICSRs)& Severe Adverse Events (SAEs) to the team using ARGUS safety database.

• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, procedures and in accordance with client specific requirements and timelines

• Performing ICSR complete case processing /QC with Device /clinical Trails/post Marketing cases.

• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)

• Reconciliation (clinical, partners)

• QC and CASE Tracker Maintenance

• Maintain Workflow Processes lead last 5 plus months

• Submission of cases with in timelines.

• Assisting in Audits

• Personal data protection

• Product Quality Complaint handling and interaction with Quality Assurance

• Medical Information interaction

• MedDRA and WHO coding

• Database Outputs and Reports (including data for monthly reporting to clients)

• Workflow & resource management

• Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)

• Mentoring and training of new and more junior employees within the department

• Support of PV processes related to the ICSR management within Prime Vigilance and to clients

• Performing activities in the scope of ICSR management unit within agreed extent and timeframe.

FEB 2021 – JUL 2021 Operational Specialist -III IQVIA, New Jersey

• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.

• Knowledge of Book In, duplicate check, Follow-ups, Triage, Data entry, QC for cases of different

• Health Authorities (EMA, MHRA, Takeda etc).

• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting, and tracking incoming - Adverse Event (AE)/endpoint information.

• Determining initial/update status of incoming events, database entry.

• Data verification and validity check (Validity Assessment and Triage) and Case Book In and

• Registration Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.

• Ensure to meet quality standards per project requirements.

• Ensure to meet productivity and delivery standards per project requirements.

• Ensure compliance to all project related processes and activities.

• Liaise with different functional team members, e.g. project management, clinical, data management

• Knowledge of narrative writing.

APR-2014 – FEB 2015 Pharmacovigilance Specialist PARAXEL

• Assess adverse event case reports stemming from pre-clinical studies, post- marketed and literature sources.

• Do quality control of key data fields, and update the safety database per pharmacovigilance

• conventions.

• Perform quality check for case reports as per client defined Key performance indicators ensuring the accurate case completion and reporting.

• Generate standard regulatory reports and check for consistency between narrative and related fields.

• Maintain references and other Medical Information resources for Pharmacovigilance and Drug Safety measures.

• Receive and initially process product complaints, forward information to the Quality Assurance Manager.

• Ensure data accuracy, clinically valid case assessment, regulatory reporting status assessment, and follow-up completed on pharmacovigilance cases.

• Maintain a log, compliance information and filing system for all pharmacovigilance cases.

• Provide pharmacovigilance training to internal staff, and external partners, as required.

• Train new hires on case processing conventions, mentoring them to confidently address the queries, assist them in completing the competency/sign off test cases.

• Participate in departmental and various cross-functional project teams that may include Regulatory, and Medical Affairs.

• Directly responsible for ensuring those adverse events are processed, analysed and reported

• according to Corporate SOP.

APR 2013 – MAR 2014 Pharmacovigilance Analyst PARAXEL

• Medical and Regulatory Assessment (MRA) of Individual Case Safety Reports

(ICSRs) (including serious and non-serious health record/cases from unsolicited and solicited origin).

• Identify and handle Suspected Unexpected Serious Adverse Reaction reports

(SUSARs) for

• Investigational purposes.

• Ensure proper coding of events and drugs for cases to ensure correct forwarding to the relevant

• Therapeutic Area Teams and Licensing Group.

EDUCATION AND TRAINING

PERSONAL SKILLS

• Document management/privacy/follow-up information obtaining and documenting for ICSRs.

• Pharmacovigilance event ranking/using the always serious list/rush cases card/upgrading serious to non-serious, and non-serious to serious case/ Narrative Writing.

NOV 2011 – MAR 2013 Pharmacovigilance Scientist PARAXEL

• Work as Triage/Case processor to process all incoming cases within timelines.

• Completing the communication screen, for cases, which require follow, ups.

• Coding of suspect products using the company product dictionary (CPD) and WHO dictionary,

• Coding of events, lab data, medical history, family history, and social history and product indications using MedDRA (Medical Dictionary for Regulatory Activities).

• Narrative writing for both the serious and non-serious cases as per client conventions. Sep 2007 – Jul 2009 MASTER OF MICROBIOLOGY

Lovely Professional University, INDIA

Jul 2004 – Jun 2007 BACHELOR OF SCIENCE

Himachal Pradesh University, INDIA

Language(s) English

Communication Skills Good official communication skills gained through my experience as a part of Pharmacovigilance. Job-related Skills • Leadership skills acquired through my experience as Pharmacovigilance.

• Knowledge of ARGUS 8, 7.

• In depth knowledge of coding principles, submission criteria.

• MedDRA ((Medical Dictionary for Regulatory Activities) Coding.

• Knowledge of Microsoft office (MS-Word/Excel/PowerPoint).

• Knowledge of MHRA, ICH, FDA regulations.

• Comprehensive knowledge of narrative writing and analysing medical data.

• Ability of guide and convince clients as well as colleagues in therapeutically areas.

• Hands-on experience of entering and reviewing detailed data in electronic case report form e.g. medical history, adverse events/concomitant medications, comorbid conditions and data coding using MedDRA (Adverse events), WHO-Drug (Drugs) dictionaries.

• Experience in preparing medical review-related Standard Operating Procedures

(SOPs)/Working Practices (WPs).

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