Clinical Pharmacist Pharmacy Intern

SRISHA RAJASEKAR

*********.**@************.*** +1-986-***-**** LinkedIn Boston, MA

EDUCATION

Northeastern University Sep’22 - Jul`24

Master of Science in Regulatory Affairs GPA: 4.0/4.0 The Doctor MGR Medical University GPA: 3.8/4.0

Doctor of Pharmacy (Pharm D) Oct`09 – Dec`15

SKILLS AND COMPETENCIES

• Medical device approval pathways, classification of medical devices, 510(k) submission, medical device reporting, Investigational Device Exemption, and Labelling requirements.

• Exposed to Drug Regulatory pathways IND, NDA, BLA and familiarity with 21 CFR Parts (54, 58, 56, 208, 210, 211, 312, 314, 320, 610), GLP, GCP, eCTD format, and ICH guidelines (M3, E6, S1B, S2, S6) during coursework.

• Worked on an academic project to create Target Product Profile for the drug Brexanolone.

• Prepared a regulatory Due Diligence report for a fictional pharmacy company.

• Proficient in MS Office (Word, Excel, PowerPoint). PROFESSIONAL EXPERIENCE

Clinical Pharmacist, Christian Medical College, and Hospital Oct`16 - Jul`18

• Active member of the antimicrobial stewardship committee in the hospital and revamped anti-microbial treatment regimen, by assessing prescribing patterns and optimizing the use of antibiotics in the pediatric population.

• Inspected adherence to CMC, GCP, and SOP for in-hospital manufacturing unit

• Performed pharmacovigilance activities by reporting adverse drug reactions to the Uppsala Monitoring Centre in dermatology by assessing causality and relatedness.

• Conveyed evidence-based drug information to cross-functional teams involving physicians, nurses, and other HCPs via Up-to-date database and BNF.

• Designed protocols that passed the IRB for prospective and retrospective clinical trials.

• Counselled outpatients in vernacular languages where treatment adherence was quintessential like an autoimmune condition or Paediatric neurology prescriptions.

• Effectively trained fellow hospital pharmacists by providing lectures on topics related to health care that helped to upgrade themselves in the hospital.

Safety Associate Trainee, IQVIA Apr`16 - Jun`16

• Evaluated and assessed individual case study reports (ICSR) based on seriousness, special situations received from clinical trials reports for Xarelto (rivaroxaban) with timely communication with Johnson & Johnson

• Drafted accurate and concise narratives in the SCEPTRE safety database to capture patient demographics, ADRs, concomitant/treatment drugs, and seriousness from MedWatch forms along with the coding of medical history and adverse event terms using MedDRA Assistant Professor, Sri Venkateshwara College of Pharmacy Jan`16 - Apr`16

• Instructed and trained Doctor of Pharmacy (PharmD) students on Pharmacotherapeutics and Pharmacology as a lecturer.

• Mentored and guided Pharm D internship students by providing intensive training for clinical care activities. Clinical pharmacy intern, Sri Ramakrishna Hospital, Nov`14 - Dec`15

• Analyzed, investigated, and identified adverse reactions, drug-drug interactions, and dosage modification in renal and hepatic failure patients

• Reported serious and non-serious adverse drug events/reactions and analyzed the relatedness and causality assessment from orthopedic, surgery, general medicine, and pediatric patients

• Managed inventory drug control and reviewed electronic health records on Micromedex and Idis software.

• Represented the hospital to educate in chronic disease management in rural areas.

• Assisted in hosting national webinars for doctors in the hospital. PUBLICATIONS

• A study on Prescribing Patterns of Drugs in Geriatrics using Beers Criteria in a Private Corporate Hospital

• “A case study on Essential Dosage Adjustment in Chronic renal insufficiency” in The International Journal of Pharmacology and Clinical Research.

ADDITIONAL CERTIFICATIONS

• Raps certificate on Regulatory Trends to eCTD submissions equivalent to 1 RAC point.

• Raps certificate on Mastering the 510k Procedure equivalent to 1 RAC point.

• Raps certificate on IND submission equivalent to 1 RAC point.

• Raps certificate on wellness and medical device equivalent to 1 RAC point.

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