PRANAVI KOLANUPAKA

+1-6134834249 | [email protected]

19-302 15 Macpherson Ave., Kingston ON K7M 2W8

Career Objective & Professional Summary
A drug safety expert having managerial skills with four years of experience in the healthcare arena. Resourcefulness and problem-solving ability with proficient knowledge in clinical drug safety to consistently deliver improved quality and productive results. Good team player committed to quality with relentless improvement and meeting bottom-line objectives.

Strengths & Skills
·                     Proactive participation in process improvement initiatives

·                     Exceptional Microsoft office skills and hands-on experience with Windows 10, ARISg, CTMS and familiar with basic Statistical Analysis Software (9.2) skills and electronic medical record systems like OSCAR

·                     Team player with good interpersonal skills, problem solving and decision-making abilities

·                     Adaptability to work effectively in constantly changing field-based environment

·                     Ability to manage sensitive conversations with external stake holders professionally

·                     Excellent verbal/written communication skills that aids in customer focus

·                     Strategic thinking, creativity, well-organizing and time management skills

·                     Capable of handling projects independently and advanced presentation skills

·                     Sharp, driven with a positive attitude and dedication towards work

Academic Qualifications
·                     St. Lawrence College, Kingston ON

Post-Graduate Certificate Program in Healthcare Administration                        2017- 2018

·                     Anurag Pharmacy College, Kodad, India

Master of Pharmaceutics                                                                                           2010 – 2012

·                     Talla Padmavathi College of Pharmacy, Warangal, India

Bachelor of Pharmacy                                                                                                2006 – 2010

Professional Work Experience Profile

Pharmacovigilance Scientist

Tata Consultancy Services, Pune, India                                                                           2014 – 2017

Domain Skills
·                     Clinical research and pharmacovigilance domain awareness

·                     Documentation of clinical study reports and patient narratives in accordance with the internal Standard Operating Procedures (SOPs) and external regulatory guidelines

·                     Knowledge on drug development in clinical trials (Phase I – IV)

·                     Medicine terminologies and Clinical Pharmacology.

·                     Adverse events and its reporting standards and timelines

·                     Sound Knowledge on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use – Good Clinical Practice (ICH-GCP) guidelines, Good Pharmacovigilance Practices (GVP) Modules, Safety standards and Standard operating procedures

Roles and Responsibilities
·                     Responsible for receiving serious adverse event (SAE) forms and assessed the validity, duplicate check, clinical and temporal relation

·                     Reviewed safety data for inconsistencies and contacted sites with case queries as necessary

·                     Managed spontaneous, clinical trial and solicited cases from case intake, processing to submission of adverse events within regulatory timelines and requirements

·                     Processed the adverse event reports according to applicable regulations, guidelines, SOPs and project requirements within the specified timelines by meeting the quality standards

·                     Assessed listed-ness in suspected cases for both investigational medicinal product and comparators

·                     Prioritized the Suspected Unexpected Serious Adverse Reactions (SUSARs), pregnancy cases and the Individual Case Safety Reports (ICSRs) which have licensee timelines

·                     Participated in quality and compliance meetings as required

·                     Resolved queries and discussed weekly and monthly error rate review of the mentees

·                     Databases worked on; ArisG, Rave medidata and Citrix

Central Pharmacy Manager

Maxcare multispecialty hospital, Telangana, India                                                 2013 – 2014

Management Skills
·                     Demonstrated leadership, team work and strong communication skills

·                     Built productive relationships

·                     Management of finances and facility

·                     Proposed solutions to business problems

·                     Identified the interests and preferences of stakeholders

·                     Maintained medical records with accuracy

Roles and Responsibilities
·         Inventory record keeping and control of medicines to detect any shortages or discrepancies

·         Purchased medicine and returning near expiry

·         Handled and maintained records of narcotic drugs separately

·         Increased total retail revenue of pharmacy by 75% while maintaining excellent patient care and collaborative drug therapy management with healthcare professionals

·         Served as an effective liaison between healthcare team and the community to improve drug safety and therapeutic outcomes