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[QUOTE=Guest;224251]Bhawna Khaneja
 bhaw_khaneja AT yahoo.co.in 
Profile
- Competent, diligent & result oriented professional, offering 4 plus years of extensive cross-functional experience in successfully & consistently delivering the responsibilities.
- Motivated, high-energy educator with demonstrated track record in fostering student learning.
- Successfully developed and conducted training programs facilitating professional growth & development of the staff hence resulting in higher levels of employee satisfaction, retention rates and increased efficiency & profitability
Professional Experience
Career Summary
Apr 2012 - ongoing Chief Pharmacovigilance Specialist at Quantum Solutions India
Nov 2010 - Mar 2012 Senior Quality Analyst, Quantum Solutions India
April 2010 - Oct 2010 Senior Quality Scientist, Quantum Solutions India
Nov 2009 - Mar 2010 Quality scientist, Quantum Solutions India
July 2008 - Oct 2009 Pharmacovigilance scientist, Quantum Solutions India
Professional Knowledge/ Research Experience
[b]- Management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programmes) which includes [/b]:
- 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
- conducting duplicate searches prior to initiation and identifying potential duplicates
- managing duplicate couples/cases appropriately
- coding 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 Company comment if required
- data validation i.e. cross checking against source documentation. 
[b]- Expertise in MedDRA coding in accordance with “MedDRA Term Selection [/b]: Points to Consider”
- Expertise in managing safety data on various safety databases
- Maintaining an excellent 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
- Volume 9a 
- FDA guidelines
- CIOMS
- Coded over 3500 cases till date. 
- Handled 225+ cases and 300+ studies
- Worked on old cases, project, reconciliations
[b]- Experience in the following therapeutic areas [/b]:
- Oncology
- Infections and Infestations
- Dermatology
- Cardiovascular
- Rheumatology
- Immunology/Autoimmune Diseases
- Metabolic disorders
- Hematology
- Virology
- Psychiatric and CNS Disorders
[b]- Expertise in [/b]:
- report nullification (decision making and processing) and case merging into a ‘Master’ case
- reconciliation of safety and clinical databases
- clinical narrative writing
- end of study blind break plan writing and processing
- working with E2B cases received from business partners 
- literature case review and coding
[b]- Literature experience [/b]:
Have experience in review and validity assessment of articles, triage, duplicate searches, registration, MedDRA coding, AE text writing, QC of literature (both clinical and spontaneous) reports, Query identification and tracking, Addition of company comment
- Maintaining awareness of global regulatory reporting obligations and organizational workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
- Participated in various client audits.
- Expertise in handling the ERP systems (enterprise resource planning)
[b]Quality experience [/b]: 
[b]- Quality Control/Quality Review [/b]: performing quality review of ICSRs to ensure high quality of the safety reports in accordance with client SOPs and regulatory requirements.
- Preparing quality matrix for the reviewed ICSRs and correlating the degree of accuracy in ICSR coding.
- Guiding and conducting training for the drug safety associates on different levels of case coding so as to ensure a high degree of accuracy and quality.
[b]Duplicate Detection for regulatory authority [/b]:
- Identifying potential duplicates in the Eudravigilance database for regulatory authority.
- Processing of duplicates and informing the regulatory authority for the duplicate case reports.
- Querying the competent authorities, MAHs and pharmaceutical companies for additional information on individual case safety reports.
- Quality review of randomly selected individual case safety reports in accordance with the regulatory authority SOPs and work instructions.
- Preparation of quality matrix for drug safety associates and conducting ad-hoc training on various aspects of duplicate detection as per the regulatory authority specifications. 
[b]Periodic Safety Update Reports and Drug Safety Reports [/b]: 
- Extensive experience in periodic safety data reports including PSURs, case narratives of PSURs, addendum reports and Summary Bridging Reports across multiple clients.
- Handling responsibility for preparation of aggregate reports in accordance with customer conventions or guidelines and SOPs including triage and summarization of literature search result and inclusion in aggregate case report.
- Completes and ensures completion of signal detection related projects/reports including DSR and Medical Evaluation assessment group in accordance with customer requirements.
[b]Query management [/b]: 
- Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies
- Sending queries to ensure timely regulatory completion of frontloaded narrative writing in clients' database for PSUR
- Responding to clients/customers in a timely manner
Thesis Work
- Potential of lactonases as quorum quenching enzymes and their applications.
Training
- “Antibiotic Susceptibility of Lactobacillus sp. isolated from common Indian dairy products” at Thapar Institute of Engineering and Technology, Patiala
Seminars Delivered
- Laccases-versatile enzymes
- Yeast to Hybrid Technology
- RNA interference and its applications
- DNA footprinting and its applications
- Influenza Vaccine
- Enzymes and procedures involved in starch processing
- Ion Exchange Chromatography
- Probiotics and their benefits
Technical skills
- Basic Microbiological Techniques
- Bio-Analytical Techniques
- Molecular biological techniques
Management Skills
- Handling the task of updating the team regularly as per the requirements of the management
- Managing and dividing the task in contingent work situations
- Being consulted by the management in meeting the project deadlines
 Computer skills
- Well versed in Microsoft Word, Excel, Power Point, C language, Internet and Web Designing (HTML, DHTML, Front page, Page Maker, CorelDraw, Adobe Photoshop).
Other Key Achievements
- Topper in Masters of Mass Communication (MMC) - 1st year examination (2010-2011)
- Qualified the GATE entrance examination in the year 2005-2006
- Topper in B.Sc (H.S.) II and III year
- Topper in 12th standard examinations in I.C.L. Public School
- Served at the post of Vice-President of Department of Microbiology, Panjab University for the year 2007-2008
- Served at the post of Department Treasurer in Department of Microbiology, Panjab University for the year 2006-2007
- Served at the post of General Secretary of Department of Microbiology, Panjab University for the year 2005-2006
- First Prize winner in basketball match at the microbiology sports meet in the year 2006-2007
- First Prize winner in basketball match at I.C.L. Public School in the year 2001-2002
- Participated in various inter-school debates, declamation contests, science quiz and one-act plays
Educational Qualification
- 2010-2012 - Masters in Mass Communication (MMC) from Guru Jambheshwar University of Science and Technology, Hisar; result awaited for 2nd year
- 2006-2008 - M.Sc (H.S) from Department of Microbiology, Panjab University, Chandigarh
- 2003-2006 - B.Sc (H.S) from Department of Microbiology, Panjab University, Chandigarh
- 2001-2002- 12th class from I.C.L Public School, Rajpura
- 1999-2000 - 10th class from I.C.L Public School, Rajpura
Seminars/Conferences Attended
- Attended Symposium on “Microbial Boons- Challenges Ahead” held at PanjabUniversity, Chandigarh on October 23, 2007
- Attended “Microcon-(NW) - 2007, Indian Association of Medical Microbiologists, North-West Chapter” held at Dayanand Medical College and Hospital, Ludhiana on October 6, 2007
[b]- Attended Indo-US Symposium on “Stem Cell Identification and Characterization [/b]: Role of Molecular Markers” held at Panjab University, Chandigarh on February 8, 2007
- Attended National Symposium on Advances in Biotechnology held at Sanatan Dharma College, Sector 32-C, Chandigarh on February 3, 2007
Personal Skills
- Always achieving the required target well ahead of scheduled timeframe. Workaholic by nature.
- Believes in submitting high degrees of quality and standards
- Getting regular appreciation for work quality and compliance
Other Skills/Interest/Hobby
- Good Communication skills
- Fluency in writing and spoken English
- Reading books, newspapers, cooking, art and craft
- Head girl and sports captain while in school[/QUOTE]

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