Shilpa Goel

CAREER OBJECTIVE:

Experienced HCP (DENTIST), seeking a challenging position in Drug Safety and Pharmacovigilance with a view to utilize my technical knowledge, logical and analytical skills in the field of medical towards professional growth and development.

12+ years of Clinical Experience as a DENTAL SURGEON.

SKILLS AND KEY ACHIEVEMENTS:

●Experienced in Drug Safety/Pharmacovigilance, collaborating as a strong team player to address pharmaceutical safety issues related to Drugs, Biologics, and Medical Devices.

●In-depth knowledge of FDA, EMA and ICH safety reporting regulations, SOPs and GCP guidelines

●Well versed with data entry of case reports in ARGUS Safety and writing medical narratives.

●Remarkable knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions

●Proficient in data entry and drug safety database

●Comprehensive knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements, and guidelines

●Assuring that the system for tracking processing, distribution and reporting of AE reports is correctly compiled and consistent to monitor compliance with internal and regulatory deadlines

●Preparation of periodic aggregate safety reports (ASRs) (e.g. PSUR, PADER) for submissions to regulatory agency.

●Working knowledge of global regulatory safety reporting requirement

●Proficient in reviewing adverse events as per policies and procedures.

●Proficient knowledge of MedDRA and WHO-DD dictionary.

STRENGTHS:

●Ability to work in an environment of rapidly changing priorities and workload

●Ability to manage multiple activities and assignments; ability to work both as a member of a team and

in an independent, self-directed manner

●Ability to prioritize, manage and organize work to meet timelines and to meet the attention of detail

required to successfully complete assignments

●Ability to effectively interact with multiple cross functional departments to produce quality written

documents

●Ability to make sound decisions relating to the advancement of the company mission and goals

●Good knowledge on Safety Data Exchange Agreements and Safety Management Plans, and

Reconciliation activities.

● Ability to proficiently utilize MS Office and other required software

EDUCATION:

●Drug Safety and Pharmacovigilance Program with ARGUS training and INTERNSHIP (2016) Sollers Institute, New Jersey, USA

●Bachelor of Dental Surgery, GOLD MEDALIST (1996-2001)

Govt. Dental College, Amritsar, Punjab, INDIA

●PG Certificate course (2005-2006) in Health & Family Welfare Management

Ministry of Health & Family Welfare, New Delhi, INDIA

JOB EXPERIENCE:

DRUG SAFETY ASSOCIATE in Drug Safety and Pharmacovigilance at SOLLERS INSTITUTE since APRIL 2016.

●Evaluated the source document for completeness and extracted relevant information from the source document.

●Triaging/Prioritized cases based on seriousness of adverse event and regulatory clock start date in accordance with company SOP and global regulatory timelines for expedited reporting.

●Processed ICSR from various sources such as clinical trials, post marketed, literature, solicited non-serious and serious adverse event cases.

●Performed duplicate case search and accurately captured patient, product, and event data in Oracle Argus safety 8.0

●Performed accurate and consistent coding of medical history, laboratory and other investigational test results, adverse event terms using MedDRA 18.0

●Performed accurate and consistent drug coding using WHO drug dictionary (WHO DD)

●Wrote accurate and detailed narratives ensuring that all the relevant information is presented in the chronological order of occurrence.

●Accurately captured listedness/expectedness of adverse events researching USPI and company core data sheet.

●Documented in contact log decisions made or actions taken at the time of data entry.

●Responsible for detailed evaluation of the case and forwarding it to Medical reviewer for company’s comment.

●Responsible for rechecking the case in the finalization stage of work flow for correctness and completeness and forwarding the case for distribution.

Worked as DENTAL SURGEON in the following dental hospitals/clinics:

●June 2012 – June 2015

oWorked at Smiline Dental Hospital Hyderabad, INDIA

ohttp://www.smiline.com/index.html

●August 2008 – December 2009

oWorked with Dr. Smita Aggarwal (Implantologist), Greater Noida, UP, INDIA

●August 2007 – August 2008

oWorked with Dr. Atul Talwar (MDS Pedodontist) at Sarita Vihar, New Delhi, INDIA

●May 2007 – July 2007

oWorked with Dr. Rohit Paul (MDS Endodontist) at Vaishali, Ghaziabad, UP, INDIA

●October 2004 – December 2005

oWorked with Dr. Binita Srivastava (MDS Pedodontist) at Noida, UP, INDIA

●May 2004 – September 2004

oWorked with Dr. Manpreet Kaur Chugh (MDS Orthodontics) at Patiala (Punjab), INDIA

●April 2003 – April 2004

oWorked with Dr. (Col.) V.S. Battu (MDS Oral Surgery) at Puran Charitable Dental Clinic, Chandigarh, INDIA

●August 2001 – March 2003

oWorked at Civil Dispensary, Sector 20 D Chandigarh, INDIA

●Conducted dental checkup survey in St. Stephan School, Sector 45-B, Chandigarh, INDIA

●Participated in the camp organized at Civil Dispensary Rajpura (Punjab), INDIA

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