Safety and Pharmacovigilance Specialist Resume

SUMMARY:

Educational Commission for Foreign Medical Graduates (E.C.F.M.G) certified Physician with over 9 years experience in clinical medicine and public health, and 5 years in drug safety / pharmacovigilance.
As a District Medical Officer, I provided comprehensive medical, obstetrical and surgical care to patients presenting at a district hospital, which was a referral center for many primary health care facilities. In the same role, I was privileged to manage district infrastructure, personnel and finances.
I organized educational and health campaigns, supervised the implementation of district health projects, recruited district staff and provided training as needed.
In my role as a drug safety specialist, I used my knowledge of the conduct and monitoring of clinical trials in accordance with International Conference on Harmonization, Good Clinical Practice, and other regulatory bodies’ guidance to process and enter data from clinical trials into Enterprise.
As a senior drug safety specialist, I train and orientate new hires, prepare safety reports and narratives, answer pharm quarries, process 24 hour notifications, and assisted with coverage of the Confidential phone line.
As an instructor, I guided, coached and empowered students nursing and medical assistant students to pursue and achieve academic excellence, with a view of changing their lives through education.

AREAS OF EXPERTISE:

COMPUTER SKILLS:

Hardware: Intel - based PC

Software: Microsoft Office (Word, Excel, PowerPoint, Outlook).

WORK EXPERIENCE:

Confidential

Safety and Pharmacovigilance Specialist

Responsibilities:

Responsible for processing of all Serious Adverse Events (SAEs)/Expedited Adverse Events (EAEs) transmitted to the Confidential groups including the Confidential for Division of Cancer Treatment and Diagnosis (DCTD), Confidential - sponsored clinical trials.
Perform quality control (QC) checks of SAE/EAE reports, triages for completion and accuracy, and reviews source documentation. Communicates with clinical sites to obtain complete and accurate information regarding EAE reports; communicates with Investigational Drug Branch (IDB) Senior Investigators notification of unexpected Grade 4 and 5 events.
Prepares Food and Drug Association (FDA) IND Safety Reports at the request of IDB Senior Investigators.
Performs QC of data entered into Confidential -supported database; prepares Investigator Notifications, Action Letters at the request of IDB Senior Investigators.
Performs searches for previously reported AEs through AdEERS.
Train new hires, answers pharm queries, and present reports to IDB monthly meetings.

Confidential, Silver Spring

Faculty

Responsibilities:

Develop curriculum and syllabi. Instructs assigned medical courses in accordance with course competencies/ objectives.
Monitors, evaluates and documents students’ progress through observation, tests and examinations in theory and practice.
Coaches, guides and empowers students to achieve optimum success.

Confidential, Cameroon

District Medical Officer

Responsibilities:

Was responsible for providing senior clinical leadership, fostering superior quality patient care, developing strategic goals and direction, and providing for the timely recruitment and retention of the medical staff at the District Hospital.
Provided comprehensive medical and surgical care to patients in both in-patient and out-patient settings.
Planned, supervised, and ensured the implementation and reporting of preventive health and community outreach programs.
Managed district hospital personnel, resources, and projects.
Provided community education and counseling.
Provided in-service training for health district employees, and supervised training of student nurses during externship.