Milky C Florent
250 Central Ave. Apt. 316. Newark NJ 07103
Mobile. (973)954-0323
begin_of_the_skype_highlighting              (973)954-0323      end_of_the_skype_highlighting
E-mail [Send email using form at bottom]
OBJECTIVE
To obtain a  position in a pharmaceutical company, in different areas such as: 
pharmacovigilance, clinical, medical, sales & marketing, to maximize legal
understanding skills with quality assurance, compliance program development, and
training experience. 
EDUCATION
Seton Hall University School of Law, Newark, NJ. 
MSJ  in Health Law and Intellectual Property Law, May 2010. 
Health Care Compliance Certification Program,  June 2009. 

Universidad Central de Venezuela,  Caracas-Venezuela. 
Business Strategic Management Certification Program, April 2009.
Activities: First International Congress of Abramd. Speaker. Sao Paulo-Brazil.
August 2008. 
            
           Bachelor in Pharmaceutical Science, Major in Toxicology.  July 2007.
Activities:  II Pharmaceutical Technology Congress. Caracas-Venezuela. July
2005. 
“Diagnosis & Prevention of Cardiovascular Disease Symposium. Speaker.
Caracas-Venezuela May 2005
First National Congress of Pharmaceutical Practice in Venezuela.
Caracas-Venezuela January 2005. 
“The Pharmacist Venezuela needs” Symposium. Caracas – Venezuela. November 2004.


PROFESSIONAL EXPERIENCE
Wyeth Pharmaceutical. Caracas-Venezuela. www.wyeth.com (Trained in Collegeville,
PA)
Safety & Compliance Officer. November 2007 to May 2009.
Pharmacovigilance Activities:
•	Collect AE information, prepare narrative and processed AE based on regulatory
requirements. 
•	Perform assessment and identify all ICRS. 
•	Processed and reviewed individual case safety reports for clinical trials and
marketed products. 
•	Participated in compliance activities related to investigation and corrective
actions for deviations from case processing procedures. (Time deviations).
•	 Identified, analyzed and proposed recommendations and corrective actions for
late case submission to local and international authorities. 
•	Identified, analyzed and proposed recommendations and corrective actions for
deviation of Medical Department internal SOPs. 
•	Trained new employees and peers on policies and operating procedure regarding
safe data reporting. 
•	Performed pharmacovigilance and risk management activities for specific
products.
•	Prepared and reviewed periodic safety reports (PSUR) in accordance with
regulatory requirements. 
•	Conducted signal detention and evaluation according to SOPs and guidelines.
Monitored all Pharmacovigilance activities. 
•	Prepared drug safety reports. Assigned appropriate MedDRA coding for each
case. 
•	Contributed to regulatory authority submissions.
•	Knowledge of International Drug Surveillance requirements, FDA requirements
for drug safety reports. 
•	Conduct and supervise Clinical trials. Comply with SOP and FDA requirements. 

Labeling Activities: 
•	Responsible for planning, directing, leading, and coordinating the process of
labeling for all Wyeth products marketed in Venezuela.
•	Overall experience in regulatory affairs and submissions of SAEs to local BoH
in compliance with local and FDA requirements. 
•	Responsible for maintenance and the translation of safety sections of the Core
Data Sheet. 
•	Translate and submit to local board of health (BoH) Drug Product Artwork-
Regulatory art work.  
•	Implement decisions and agreements for drug product artwork and communicate
them to artwork center. 
•	Create database for product art work for all Wyeth products marketed in
Venezuela affiliate 
•	Create and assure timeline implementation of art work for all Wyeth Products
marketed in Venezuela affiliate. Artwork compliance program. 
	
                 Commercial Compliance:  
•	Reviewed company’s overall compliance program. Modify Corporate Compliance
Program (CCP) policies and procedures to meet government, industry and company
compliance requirements.
•	Managed all issues regarding internal control and commercial compliance
including sponsorships, donations, grants, interactions with HCPs and improper
payments. 
•	Planed and conducted periodic internal audits in order to promptly detect
situations that do not comply with local, global or Wyeth policies or
regulations. 
•	Maintain and evolve compliance training curriculum, as well as assist with or
deliver compliance related training to Sales and other colleagues.
•	Focus on Clinical –Medical, sales and marketing promotional compliance. 
•	Reviewed complaints received from internal and external sources. 
•	Investigated significant instances of noncompliance, or potential compliance
violations.
•	Reviewed and monitored the Company’s compliance training initiatives on
several topics.
•	Trained peers on policies and operating procedure regarding medical and
commercial compliance activities. 
Major achievement: Named in 2008 Champion for the Latin America Region in
project SIRENA.(Electronic Review and Approval System for Promotional Material).
Compliance achievement. 
 
Toxicology Regional Unit, Maracay-Venezuela.
Toxicologist (intern).  April- June 2007 
•	Attended all emergency cases. Responded to emergencies cases such as drug
overdoses and monitored drug therapies for patients who have certain types of
diseases. 
•	Attended and reviewed cases related to food, occupational poisoning and drug
abuse. 
•	Kept updated records of cases for the local authorities (Venezuela´s Board of
Health)
•	Identified harmful substances causing injury to patients by carrying out
laboratory and field tests.

Military Hospital. Caracas-Venezuela. 
Pharmacist. (intern).   July-October 2006
•	Dispensed prescription order to patients and prepared medical formulas.
•	Performed assessment of patients
•	Daily control of stupefacient and psychotropic substances. 



SKILLS
Working experience within pharmaceutical environment, experience in
Pharmacovigilance operations, ability to work effectively under pressure and meet
timelines, knowledge of MedDRA, writing of narrative cases, data entry into
adverse event systems such as ARISg, attentiveness to detail, excellent
interpersonal, decision-making and organization skills, strong written and oral
communication skills in English, Spanish and French. Legal writing, contract and
SOP review. Knowledge of Health Science and technology law such as: contract and
corporate law, insurance, Medicare & Medicaid, FDA & Federal Legislative and
Administrative regulations, ant kickback laws, False Claims Act, Stark, HIPPA,
medical malpractice, common law and statutory knowledge of trademark, trade
secret, copyright and Patent.  
 

PUBLICATIONS
Please see attachment. 

LANGUAGES 
Fluent in English, Spanish and French. Knowledge of Portuguese.