Amani Salama

***, *** ******* ****** **. M*j *l* Toronto, ON

ac4kye@r.postjobfree.com- Mobile: 416-***-****

HIGHLIGHTS OF SKILLS AND QUALIFICATIONS

High performing, energetic professional with medical background, expertise in pharmaceutical quality assurance, pharmacovigilance and adverse event reporting.

8 years of experience in Clinical Research organizations (CRO) focused on (Oncology, Cardiology, Gastroenterology and Endocrinology).

Deep knowledge of monitoring procedures.

Excellent knowledge of clinical trials process.

Detailed knowledge of quality assurance (QA) audits of clinical trials phase (I-VI) in compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols and pertinent regulations and guidelines (FDA, Health Canada and EMEA).

Strong communication, good interpersonal, organizational and management skills.

Expertise in using (MedDRA) for Regulatory Activities.

Proficient: MS Office (Word, Excel, and Outlook) OpenClinica and Citrix.

Bilingual, English/French.

PROFESSIONAL/WORK/VOCATIONAL EXPERIENCE

Crown Medical Research and Pharmaceutical Sciences College of Canada, Toronto, On

Lecturer (Part-time) January 2017-Present

Preparing and presenting lectures for pharmacovigilance and drug safety.

Worked with group students to prepare 10 protocols and SOPs.

Wrote multiple medical essays e.g. Chinese medicine and medical Cannabis.

HT Pharmaceuticals, Toronto, On

Clinical trials monitor (2 CROs) (Oncology) December2016-June2017

Monitoring study sites, verify subjects’ safety and adherence to Health Canada and ICH/GCP Guidelines.

Interacted with study coordinators (CRCs), Data Manager (DM) and Physician investigator (PI) to discuss queries or to obtain the missing case information.

Evaluated the risk of any deviation, analyzed the cause and assisted the site with Corrective and Preventive Action (CAPA) Plans.

Documented and reported audit findings in a timely manner and followed up all compliance issues until resolution.

Reviewing and analyzing all the medical safety data during trial conduct to ensure subjects’ safety.

Comparing source documentation and CRFs to ensure data are accurate and complete.

Discussing and responding to all the medical queries raised by the working team.

Ensuring that Adverse Events are reported appropriately, accurately and in a timely manner.

Leading team discussion for both case processing and scientific product knowledge.

Source document verification (SDV), reviewing and confirming compliance with SOP and generating queries for any protocol deviations or missing information.

Identifying quality issues and assisting the site with a corrective/preventive action (CAPA) or mitigation plan.

Amani Salama

314, 125 Parkway Forest Dr. M2j 1l9 Toronto, ON

ac4kye@r.postjobfree.com- Mobile: 416-***-****

BioPharma Services Inc., Toronto, On

QA Auditor Sept 2016-December 2016

•Participating in 6 clinical study reviews for protocol and Case Report form (CRF).

•Assisting in the review and distribution of five (10) SOPs.

•Source Documents Reviewing (SDR) and detailed reviewing of hardcopy and electronic adverse events (AE) report forms and supplementary reports.

•Assisting QA management in hosting sponsor audits and regulatory inspections.

Rising Minds Group Home (Adults with Autism), Toronto, On

Clinical supervisor November2012-August2016

Ensuring that individuals with developmental disabilities are safe, healthy, and living in a clean environment.

Ensuring the regular and consistent completion and appropriate forwarding of all necessary written documentation, including for areas of service, administration and staffing

Tawam Hospital, Al Ain, U.A.E.

Physician and Clinical Trials Monitor December2000-June2012

Monitoring the conduct of clinical trials, especially enrollment and quality of data.

Ensuring individual case reports are accurate, complete and timely for regulatory reporting purposes.

Working on data entry, query generation, data reconciliation, narrative writing and ensuring data was captured according to departmental SOP.

Reviewing CRF, Informed Consent Documents and query language/narratives.

Performing safety data entry in the database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control and ensure case reporting.

Performing quality review and checking cases for discrepancies for any errors related to labeling and narrative writing.

Completing domestic Adverse Drug Reaction (ADR)/AE forms online and submitting them in accordance to regulations and guidance documents

Creating clear, medically concise case narrative procured from relevant information in form of various source documents.

EDUCATION

Bilingual Post Graduate Certificate in Quality Assurance and Good Manufacturing Practices

June 2017 - Crown Medical Research and Pharmaceutical Sciences College of Canada, Toronto, On.

Post Graduate Diploma in Clinical Research, Drug Safety and Pharmacovigilance

2016 - Academy of Applied Pharmaceutical Sciences, Toronto, On.

Post Graduate Diploma in Internal Medicine

1992- Alexandria University, Egypt.

Medical degree (M.B.CH.B) (U.S. Equivalency: M.D. degree from a regionally accredited institution). Accreditation from Canada is in process

1986 - Alexandria University, Egypt.

REFERENCES

Available upon request

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