Drug Safety Associate Resume

SUMMARY

Experienced Medical doctor with extensive knowledge and expertise in pharmacovigilance operations including but not limited to case management, labeling, literature review and company‘s assessment along with narrative writing.
Exceptional interpersonal communication skills (verbal/written) for effective interactions with Clients, Patients and all levels of Management.

PROFESSIONAL EXPERIENCE

Drug Safety Associate

Confidential

Responsibilities:

Processed ICSR from various sources such as clinical trial, post - marketed, literature, and solicited with an accuracy and consistency using Oracle Argus Safety.
Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event information into the safety database.
Generated queries using ARGUS interface.
Performed manual coding of AEs using MedDRA dictionary for the events.
Used MedDRA frequently to code labs, historical conditions and products while processing ICSRs.
Prepared clinical narrative summaries for AE reports independently from clinical studies, literature and post-marketing reports.
Determined listedness.
Took part in the preparation of periodic/ aggregate reporting including the preparation and QC of DSURs and PSURs.
Assessed ICSRs in accordance to WHO-UMC guidelines to determine causality.
Provided company’s comments on ICSRs after medically reviewing the case and narratives.
Prepared case listing and line listing for reporting.
Worked on Empirica signal (demo) for signal detection
Configured clinical trial studies using Argus console

Clinical Support Worker

Confidential

Responsibilities:

Provided support to Operating Room and Post Anesthesia Care Unit.
Guided parents out of the OR and to the waiting area which helped develop people skills and lead me to connect to people under stressful conditions.
Provided clinical, clerical and service support to ensure smooth and efficient operation of the OR daily.
Learnt multi-tasking, initiative, judgment, problem solving and independent making decisions.
Worked collaboratively with the clinic staff and independently, as required.

Research Program Coordinator

Confidential

Responsibilities:

Research program with Confidential, about the role of Mefanemic Acid in Premenstrual Syndrome
Went to women colleges, collected data of symptom improvement and adverse events.

Medical Officer

Confidential

Responsibilities:

Department of Diagnostic Imaging.
Reported X-Rays studies.
Pediatric ultrasonography especially cranial ultrasounds.
Maintained a library of unique cases to present at weekly clinical presentation.
Fluoroscopy examinations of gastrointestinal and genitourinary tracts.
Pediatric and Obstetrics ultrasonography and doppler studies
Assisted in reporting CT scans and MRI.
Drained ascites and pulmonary effusions under ultrasonography guidance.
Follow up and made recommendations for other supporting diagnostic procedures.

Medical and Surgical House Officer

Confidential

Responsibilities:

House officer Internal Medicine and general surgery.
Rotational clinical work averaging 72 hours per week includes in following areas:
Gastroenterology with special focus on interventions like ERCP and Liver diseases, Respiratory, Oncology, hematology, infectious diseases, dermatology, rheumatology and neurology.