Resume

Sign in

Senior DSA II/ Trainer

Location:
Vasant Nagar, Karnataka, India
Posted:
May 28, 2020

Contact this candidate

Resume:

Confidential

CURRICULUM VITAE

B. NISHA RANI

Mobile: +91-973*******

Email: addhd2@r.postjobfree.com

CAREER OBJECTIVE

I am seeking a position to utilize my skills and abilities in industry that offers security and professional growth while being resourceful, innovative and flexible. I would like to work in an organization that reward hard work and will help me advance to further levels commensurate with my performance.

PROFESSIONAL EXPERIENCE:

Currently working as Senior Drug Safety Associate-II at Navitas Lifesciences, Bengaluru from Feb-2019.

Senior PV Executive at Strides Shasun PVT Ltd, Bengaluru from Dec-2016 to Jan- 2019.

Operations Specialist (Pharmacovigilance) at Quintiles India Pvt Ltd, Bengaluru from Apr-2015 to Nov-2016.

Drug Safety Analyst (Pharmacovigilance) at Accenture Pharmaceutical Services, Bengaluru from Dec-2012 to Apr-2015.

Assistant Professor at Sri Indu Institute of Pharmacy from Nov-2011 to Dec-2012.

Total work experience (1 year teaching+ 7 years PV) = 8 years. DATABASE EXPERIENCE:

Worked on SCEPTRE database.

Worked on Argus 6.0.7.8, Argus 7.0.2, Argus 7.0.4 and Argus 8.0.4 with good knowledge on database.

Worked on Empirica Trace 4.0 database.

Well versed with Med DRA and WHODD dictionaries coding and conventions. Confidential

PROFESSIONAL SYNOPSIS

Worked on legal and literature cases as well.

Trained individuals on various activities Book-in, seriousness check/triage, case processing and quality review.

Good understanding of drug safety, safety database use.

Quality Control and Assurance.

Ability to work independently under tight time constraints.

Preparation of aggregate reports.

Deviation management (compliant misses reporting).

SME for legal team and Argus.

I was one among the two people selected from legal team to train the new joiners for a new legal project acquired by the company.

Worked closely with the client, took up client clarification calls and training on daily basis for stabilizing the team.

EDUCATIONAL QUALIFICATION

Educational

Qualification

University/Board Name of Institute Year Percentage M.Pharmacy

(Pharmaceutics)

Jawaharlal Nehru

Technological University

Hyderabad

Sri Indu Institute of

Pharmacy

2011 76.7

(Distinction)

B Pharmacy Kakatiya University (KU

warangal)

Vikas College of

Pharmacy

2009 80

(Distinction)

Senior School Board of Intermediate Adarsha mahila Kalasala(Sri Chaitanya)

2005 89.8

(First Div)

High School SSC St. Ann's Girls High

School

2003 82.5

(First Div)

ACHIVEMENTS

Received "Team Champ Award" in AUG-2016 for my contribution to the team. Confidential

Received "Applause Award" in JUL-2016 for Best caption for SME (Subject Matter Expert).

Received "Applause Award" in MAY-2016 for my valuable contribution for the new Legal project. As I played a crucial role in success of the project.

Received "Applause Award" for exceptional performance on 15-JAN-2016. As my contribution had helped Legal team to report all PVA due cases at Quintiles Research India Private Limited, Bangalore.

Won "Numero Uno Award" twice for high performance at Accenture Pharmaceutical Services, Bangalore.

Implemented an idea on Standard query generation template' at Accenture Standard query generation template' at Accenture Pharmaceutical Services, Bangalore.

Won 2nd prize in debate competition conducted by "Med plus Groups" on the topic

Standard query generation template' at Accenture Should Patent Rights Be Liberalized'.

Poster presentation on Standard query generation template' at Accenture Degradent Profiling and Formulation Management' at Tech Pragna conducted by Malla Reddy group of Institutions.

Won prize at college for Organizing Chess competitions and Hosted many events.

Organized poster presentations at Sri Indu Institute of Pharmacy for "Pharma Ignite 2012".

Attended seminars in RIPE 2012 held at JNTU Hyderabad. WORK EXPERIENCE - PROJECT DETAILS

PROJECT 1:

ROLE: Senior PV Executive/ senior DSA II:

Responsibilities:

Preparation of Aggregate reports (PAPERs/PSURs/ CARs etc) within timeline according to requirements and standard operating procedures.

Check for accuracy of data entry including coding of events using MedDRA and products using WHODD. Check for correctness and completeness of narrative in chronological order. Assume responsibility for quality of cases processed. Coordinating with medical reviewers when required. Follow-up queries where necessary. Performing overall quality check for the ICSR based on metrics and KPI for the team. Preparation and update quality metrics for ICSR and publish a quality report for the team on timely basis.

Confidential

Audit and compliance:

Perform internal quality check for cases processed by vendor.

Ensure compliance of operations with governing regulatory requirements for ICSRs. Trainings and compliance to be adhered.

Preparation and audit readiness for internal and external inspections. Preparation of CAPA for audits and assure the appropriate closure within the agreed timeframe.

PROJECT: 2

ROLE: Operations Specialist (Pharmacovigilance):

Responsibilities:

To manage activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) within specified timelines as per the requirement involving Safety Data Exchange Agreement of certain products along with regulatory timelines for marketed products and investigational products for which a Legal case was filed in the Court of Law.

Key Activities:

Process adverse event reports from assigned e-room folder for legal cases as per company Standard Operating Procedures and guidelines, assesses regulatory status which is seriousness and expectedness/relatedness for maintaining regulatory compliance.

Effectively maintain the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process.

Completion of case processing (Case data entry, labelling, approval numbers, manual coding and narrative writing) and Quality review.

Clarification of unclear or illegible information from the Local Safety Officer or Call Centre and custom communication as per the project requirement.

Request deletion/Admin edit requests as necessary.

Completion of protocol request forms as necessary.

Preparation of deviation memo as necessary.

Support the generation of Annual Safety Updates, Periodic Safety Reports, and other cumulative safety reports including data retrieval, analyses and quality control. Confidential

Represent team at client meetings; contribute presentation of safety process at investigator meetings.

Participation in business continuity plan as required.

PROJECT 3:

ROLE: Seriousness Check Officer (mapped to medical approver) (Pharmacovigilance): Responsibilities:

To manage activities relating to receipt of the cases in the assigned work flow, take up the cases and assess for seriousness criteria based on the source document and upgrade the case moving it to the next work flow.

Key Activities:

Pick up cases from the assigned work flow, view the source documents and assess for seriousness via referring AESI and IME list.

Review the literature cases and confirm the seriousness and mark the criteria when applicable.

Knowledge of medical judgment to either upgrade a case to serious or downgrade it to non-serious.

Inform the respective partners to update their database when the case is upgraded.

Route the case to the respective process for further action by the case processing team.

Perform internal quality check of the cases processed by peers.

PROJECT 4:

ROLE: Screening Associate (Pharmacovigilance):

Responsibilities:

To manage activities relating to receipt of the mails in the assigned mail box, take up the mails and assess for seriousness criteria, assign day zero and regulatory timelines, nomenclature of mails and forward to the respective mail boxes for further actioning. Key Activities:

Confidential

Pick up mails from the assigned mail box, view the source documents and assess for seriousness via referring AESI and IME list.

Knowledge of medical judgment to either upgrade a case to serious or downgrade it to non-serious.

Assign day zero for the case.

Nomenclature based on the service level agreement and day zero to identify the regulatory time lines and seriousness based on the nomenclature.

Forward the mail to the respective mail box for further action by the case processing team from where it would be picked and processed.

PROJECT 5:

ROLE: Drug Safety Associate (Pharmacovigilance):

Responsibilities:

To manage activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) within specified timelines for marketed products and investigational products.

Key Activities:

Process adverse event reports from clinical trials and from marketing activities as per company Standard Operating Procedures and guidelines, assesses regulatory status which is seriousness and expectedness/relatedness for maintaining regulatory compliance.

Effectively maintain the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process.

Perform consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions.

Write narrative, PSUR comment according to the guidelines and assess causality of the event.

Approve the cases within the stipulated time frame and distribute the case to regulatory authority.

Support the generation of cumulative safety reports including data retrieval, analyses and quality control.

Represent team at client meetings; contribute presentation of safety process at investigator meetings.

Confidential

M Pharma - Final Year Project:

Topic : Formulation and Evaluation of Orally Disintegrating Tablets of Rizatriptan.

Industry : NATCO PHARMA Kothur, Mahbub Nagar, Andhra Pradesh. PERSONAL DETAILS

Name : B. NISHA RANI

Date of Birth : 24/08/1987

Nationality : Indian

Languages known : Telugu, Hindi & English.

Currently in Bangalore: Flat no: 201, Pride Ghar, 44 Tubarhalli Extension road, Opp: Sonestaa meadows, Tubarhalli, Whitefield,

Karnataka, India.

DECLARATION:

I hereby declare that all the above information is true to the best of my knowledge.

(B. Nisha Rani)



Contact this candidate