M.D. - Medical Safety Expert

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" colspan=2 height=82 BGCOLOR="#9900CC" TEXT="#080000"> <div> <FONT SIZE="6" COLOR="#FFFFCC" FACE="Book Antiqua" ><B>The Artac Seel Company, Inc.</B></FONT><FONT SIZE="3" COLOR="#FFFF99" FACE="Book Antiqua" ><B> </B></FONT><FONT SIZE="3" COLOR="#FFFF80" FACE="Book Antiqua" ><B> </B></FONT><B>   </B><A HREF="index.htm" TARGET="_top" TITLE="TASC Home Page"><U><B>Home Page</B></U></A><B> </B></div> <div> <A HREF="id45.htm" TARGET="_top" TITLE="FULLTIME POSITIONS"><U>FULL-TIME POSITIONS</U></A>   |   <A HREF="id56.htm" TARGET="_top" TITLE="CONTRACT POSITIONS"><U>CONTRACT POSITIONS</U></A>   |   <A HREF="id48.htm" TARGET="_top" TITLE="RECRUITING"><U>RECRUITING</U></A>   |   <A HREF="id46.htm" TARGET="_top" TITLE="CONSULTING"><U>CONSULTING</U></A>   |   <A HREF="id49.htm" TARGET="_top" TITLE="ABOUT US"><U>ABOUT US</U></A></div> <div> </div> </td> </tr><tr> <td valign="top" width=340 BGCOLOR="#999980" TEXT="#080000"> <div> <B>Ellen Capito-Wightman, President</B></div> <div> <B>Corp. Phone  (860) 535-4419</B></div> <div> <B>FAX (860) 535-1842</B></div> <div> <A HREF="mailto:info@artacseel.com" TARGET="_top" TITLE="mailto:info@artacseel.com"><U><B>info@artacseel.com</B></U></A></div> <div> <A HREF="mailto: ellen@artacseel.com" TARGET="_top" TITLE="mailto: ellen@artacseel.com"><U><B>E-Mail to Ellen</B></U></A></div> <bR> <bR> <bR> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <div> <A HREF="id108.htm" TARGET="_top" TITLE="Director, Compliance Regulatory Affairs"><U>Director, Compliance & Regulatory Affairs</U></A></div> <div> <A HREF="id107.htm" TARGET="_top" TITLE="Scientist II, DMPK "><U>Scientist II, DMPK </U></A></div> <div> <A HREF="id106.htm" TARGET="_top" TITLE="Exec. Dir., Early Clinical Development "><U>Exec. Dir., Early Clinical Development - Inflam. & Immunology</U></A></div> <div> <A HREF="id105.htm" TARGET="_top" TITLE="Global Medical Affairs Disease Leader (E"><U>Global Medical Affairs Disease Leader (Exec. Dir)</U></A></div> <div> <A HREF="id103.htm" TARGET="_top" TITLE="Exec. Dir., Clinical Research Physician,"><U>Exec. Dir., Clinical Research Physician, Leukemia</U></A></div> <div> <A HREF="id104.htm" TARGET="_top" TITLE="Global Exec. Dir/VP Phase 1 Leader"><U>Global Exec. Dir/VP "Phase 1 Leader"</U></A></div> <div> <A HREF="id102.htm" TARGET="_top" TITLE="Dir., Multiple Myeloma Marketing"><U>Dir., Multiple Myeloma Marketing</U></A></div> <div> <A HREF="id101.htm" TARGET="_top" TITLE="VP Clinical and Medical Affairs"><U>VP Clinical and Medical Affairs</U></A></div> <div> <A HREF="id100.htm" TARGET="_top" TITLE="Senior Dir., Translational Medicine"><U>Senior Dir., Translational Medicine</U></A></div> <div> <A HREF="id99.htm" TARGET="_top" TITLE="Director Medical Affairs Oncology"><U>Director Medical Affairs -- Oncology</U></A></div> <div> <A HREF="id98.htm" TARGET="_top" TITLE="Clinical Submission Manager"><U>Clinical Submission Manager</U></A></div> <div> <A HREF="id97.htm" TARGET="_top" TITLE="Senior BiostatisticianProgrammer Pharma"><U>Senior Biostatistician-Programmer - Pharmacovigilance </U></A></div> <div> <A HREF="id96.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety "><U>Senior Medical Reviewer, Drug Safety </U></A></div> <div> <A HREF="id95.htm" TARGET="_top" TITLE="Director, Solid Tumor Marketing"><U>Director, Solid Tumor Marketing</U></A></div> <div> <A HREF="id94.htm" TARGET="_top" TITLE="Director, Regulatory CMC"><U>Director, Regulatory CMC</U></A></div> <div> <A HREF="id93.htm" TARGET="_top" TITLE="Director IM Forecasting and Planning"><U>Director IM Forecasting and Planning</U></A></div> <div> <A HREF="id92.htm" TARGET="_top" TITLE="Senior Mgr., IVRS Central Management"><U>Senior Mgr., IVRS Central Management</U></A></div> <div> <A HREF="id91.htm" TARGET="_top" TITLE="Manager, Safety Quality Assurance, Globa"><U>Manager, Safety Quality Assurance, Global Drug Safety</U></A></div> <div> <A HREF="id90.htm" TARGET="_top" TITLE="Research Scientist I / II"><U>Research Scientist I / II</U></A></div> <div> <A HREF="id88.htm" TARGET="_top" TITLE="Associate Director/Director, Regulatory "><U>Associate Director/Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id75.htm" TARGET="_top" TITLE="AD/Trail Management, Translational Medic"><U>AD/Trail Management, Translational Medicine(TM)</U></A></div> <div> <A HREF="id72.htm" TARGET="_top" TITLE="Associate Director, Regulatory Affairs, "><U>Associate Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id71.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Operat"><U>Associate Director, Manufacturing Operations</U></A></div> <div> <A HREF="id53.htm" TARGET="_top" TITLE="Compliance Project Sr. Specialist "><U>Compliance Project Sr. Specialist </U></A></div> <div> <A HREF="id65.htm" TARGET="_top" TITLE="Senior Director, Lead Global Product Saf"><U>Senior Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id76.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety"><U>Senior Medical Reviewer, Drug Safety</U></A></div> <div> <A HREF="id52.htm" TARGET="_top" TITLE="Director, Lead Global Product Safety Phy"><U>Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id86.htm" TARGET="_top" TITLE="Clinical Research Scientist, Oncology"><U>Clinical Research Scientist, Oncology</U></A></div> <div> <A HREF="id85.htm" TARGET="_top" TITLE="Associate Director, GLP Quality Assuranc"><U>Associate Director, GLP Quality Assurance </U></A></div> <div> <A HREF="id84.htm" TARGET="_top" TITLE="Medical Writer, Scientific Communication"><U>Medical Writer, Scientific Communications</U></A></div> <div> <A HREF="id81.htm" TARGET="_top" TITLE="Director/Sr. Director, Regulatory Affair"><U>Director/Sr. Director, Regulatory Affairs</U></A></div> <div> <A HREF="id80.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Ops"><U>Associate Director, Manufacturing Ops</U></A></div> <div> <A HREF="id79.htm" TARGET="_top" TITLE="Manager, Nonclinical Development Q.A."><U>Manager, Nonclinical Development Q.A.</U></A></div> <div> <A HREF="id78.htm" TARGET="_top" TITLE="Clinical Research Physician Oncology/Hem"><U>Clinical Research Physician- Oncology/Hematology</U></A></div> <div> <A HREF="id77.htm" TARGET="_top" TITLE="Clinical Research Physician Inflammation"><U>Clinical Research Physician- Inflammation</U></A></div> <div> <A HREF="id59.htm" TARGET="_top" TITLE="Quality System Application Specialist"><U>Quality System Application Specialist</U></A></div> <div> <A HREF="id87.htm" TARGET="_top" TITLE="Assoc Director DMPK"><U>Assoc Director DMPK</U></A></div> <div> <A HREF="id83.htm" TARGET="_top" TITLE="Mgr., Global Project Mgt. Admin."><U>Mgr., Global Project Mgt. Admin.</U></A></div> <div> <A HREF="id82.htm" TARGET="_top" TITLE="Project Manager Clinical Supplies"><U>Project Manager Clinical Supplies</U></A></div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f0ccffff00.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">M.D. - Medical Safety Expert</B></div> <div> <A HREF="id64.htm" TARGET="_top" TITLE="Sr. Manager, Manager Pharmacokinetics"><U>Sr. Manager, Manager Pharmacokinetics</U></A></div> <div> <A HREF="id60.htm" TARGET="_top" TITLE="Manager/Sr. Mgr. Q.C. Laboratory"><U>Manager/Sr. Mgr. - Q.C. Laboratory</U></A></div> <div> <A HREF="id74.htm" TARGET="_top" TITLE="Investigation Mgr., Devel. Quality"><U>Investigation Mgr., Devel. Quality</U></A></div> <div> <A HREF="id47.htm" TARGET="_top" TITLE="Clinical Pharmacology Scientist"><U>Clinical Pharmacology Scientist</U></A></div> <div> <A HREF="id55.htm" TARGET="_top" TITLE="Global Product Safety Physician"><U>Global Product Safety Physician</U></A></div> <div> <A HREF="id63.htm" TARGET="_top" TITLE="Assoc. Director Global Drug Safety"><U>Assoc. Director - Global Drug Safety</U></A></div> <div> <A HREF="id61.htm" TARGET="_top" TITLE="Sr. Prin/Assoc. Dir. Biostatistics"><U>Sr. Prin/Assoc. Dir. - Biostatistics</U></A></div> <div> <A HREF="id57.htm" TARGET="_top" TITLE="Manager Regulatory Affairs"><U>Manager - Regulatory Affairs</U></A></div> <div> <A HREF="id69.htm" TARGET="_top" TITLE="Senior Director Clinical Ops"><U>Senior Director - Clinical Ops</U></A></div> <div> <A HREF="id70.htm" TARGET="_top" TITLE="Senior Research Scientist"><U>Senior Research Scientist</U></A></div> <div> <A HREF="id68.htm" TARGET="_top" TITLE="Senior Mgr., Med. Sci. Writing"><U>Senior Mgr., Med. & Sci. Writing</U></A></div> <div> <A HREF="id66.htm" TARGET="_top" TITLE="Senior Clinical Research Scientist"><U>Senior Clinical Research Scientist</U></A></div> <div> <A HREF="id67.htm" TARGET="_top" TITLE="Clinical Research Manager"><U>Clinical Research Manager</U></A></div> <div> <A HREF="id62.htm" TARGET="_top" TITLE="Clinical Trial ManagerOncology"><U>Clinical Trial Manager-Oncology</U></A></div> <div> <A HREF="id50.htm" TARGET="_top" TITLE="Clinical Research CRA"><U>Clinical Research CRA</U></A></div> <div> <A HREF="id51.htm" TARGET="_top" TITLE="Senior Director Oncology"><U>Senior Director - Oncology</U></A></div> <div> <A HREF="id54.htm" TARGET="_top" TITLE="Data Manager II"><U>Data Manager II</U></A></div> <bR> </td> <td valign="top" height=398 BGCOLOR="#FFFFCC" TEXT="#080000"> <div> <B><U>M.D. - Medical Safety Expert</U></B></div> <bR> <div> <TABLE BORDER="6" CELLPADDING="7" CELLSPACING="7" WIDTH="677" BORDERCOLORLIGHT="#660099" BORDERCOLORDARK="#660099" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP BGCOLOR=#FFFFFF HEIGHT= 1879 ><NOBR><bR> <div> <B>M.D. Medical </B></div> <div> <B>Safety Expert</B></div> <bR> <div> <B>Posted Feb. 26, 2007</B></div> <bR> <div> <B><IMG SRC="0e396330.jpg" border=0 width="150" height="51" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></B></div> <bR> <bR> <div> <B>Parsippany, New Jersey</B></div> <bR> <div> <B>3 to 5 Years Experience</B></div> <div> <TABLE BORDER="0" CELLPADDING="1" CELLSPACING="1" WIDTH="210" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="VOID" RULES="NONE" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=CENTER HEIGHT= 13 WIDTH="206"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="13" ALIGN="bottom" WIDTH="206" HSPACE="0" VSPACE="0"></tD> </tR> </TABLE></div> <bR> </NOBR></tD> <tD VALIGN=CENTER BGCOLOR=#FFFFFF WIDTH="386"><div> <B>JOB DESCRIPTION: </B></div> <bR> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Signal detection and risk management </div> <div> • Preparation of regulatory documentation, including but not limited to PSURs, PADERs, and QA Reports. </div> <div> • Perform medical responsibilities in regard to in-licensing or Rx to OTC swith products including but not limited to safety evaluations, report writing, data analysis and preparation of NDA and MA submissions. </div> <div> • Perform daily responsibilities in accordance to all applicable SOPs, conventions and company policies </div> <div> • Research, review and evaluate medical assessments (Determine need on which cases will be ARGUS databased) </div> <div> • Medical quality assurance of processed data and internal drug safety procedures </div> <div> • Ensure the accurate and timely processing of analytical test results from medical/technical complaints </div> <div> • Quality checking of databased adverse event cases in the ARGUS Safety Database while ensuring both medical coding of Adverse Events with the MedDRA dictionary and product coding with the WHO dictionary is accurate </div> <div> • Perform searches in the ARGUS Safety Database as well as evaluating the results </div> <div> • QA and medical evaluation of expedited reports, legal case review and reports generated in ARGUS (Examples: Annual Product Review Reports, ad hoc searches, trending reports, Lack of Efficacy Reports and US Periodic Safety reports) </div> <div> • Review of literature searches including OVID prompts, Intra/Internet Search, The Pink/Tan Sheet search; includes global discussions (NCH-HQ and Canada) </div> <div> • Evaluation of searches for discussions at the ADE Committee Meeting as well as heading the meeting </div> <div> • Assist in the review and development of SOPs, Working Procedures and Drug Safety medical and databasing conventions (including global harmonization) </div> <div> • Assist in the creation of drug safety relevant product information (Examples: Updating product core data sheets) </div> <div> • Assist in review of all protocols, marketing questionnaires and quality of life surveys to ensure safety reporting obligations are adequately covered </div> <div> • Responsible for timely creation of US mandatory Health Authority reports and the liaison with NCH-HQ regarding non-US mandatory Health Authority reports </div> <div> • Assuring that Third Parties are receiving drug safety relevant data/reports in a timely manner according to the contracts </div> <div> • Liaise with Regulatory Affairs for discussions of new FDA guidelines, regulations, etc. </div> <div> • Liaise with Legal Department regarding medical evaluation of Legally/Potentially Legal cases </div> <div> • Liaise with Quality Assurance regarding medical evaluation of Technical/Product complaints </div> <div> • Liaise with Clinical Research regarding medical evaluation of reported SAEs </div> <div> • Liaise with Marketing Research regarding medical evaluation of reported AEs </div> <div> • Liaise with Marketing for updates regarding medical evaluation of drug safety relevant labeling changes and product launches </div> <div> • Assist with special projects as required and instructed (Example: Medical quality assurance of processed data and internal drug safety procedures, attendance of all applicable departmental and global meetings, development and assistance of all applicable drug safety training, etc. </div> <div> • Travel as needed </div> <div> • All work will meet quality requirements consistent with: </div> <div> o Novartis standards </div> <div> o Health authority standards </div> <div> o Industry standards </div> <div> Minimum requirements Position Requirements & Education </div> <div> • Medical Doctor (MD or equivalent from an accredited institution) </div> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <bR> <div> •<FONT SIZE="2" COLOR="#000033" FACE="Arial" > 3 years industry experience specifically in Drug Safety </FONT></div> <div> • OTC experience is desirable </div> <div> • Previous knowledge of medical evaluation of Drug Safety relevant information and medical coding is desirable </div> <div> • Previous experience in preparing US Periodic Reports and PSURs is desirable </div> <div> • Knowledge in ARGUS Drug Safety Database preferable. Equivalent database experience acceptable </div> <div> • Excellent English language written and oral communication skills </div> <div> • Highly responsible, with the ability and willingness to initiate and demonstrate autonomy of thought and action </div> <div> • Ability to work with minimal supervision </div> <div> • Ability to meet and maintain very tight deadlines while maintaining organization and excellent punctual work ethics </div> <div> • Excellent organizational and communication skills </div> <div> • Ability to multi-task </div> <div> • Maintain a professional and discrete attitude </div> <div> • Computer literate </div> <div> • Proficiency in PowerPoint, Excel, Lotus Notes, Word for Windows is essential </div> <bR> <div> Behavior </div> <div> • High ethical and moral attributes </div> <div> • Open and honest </div> <div> • Ability to quickly adjust to changing priorities </div> <div> • Ability to work with minimum supervision </div> <div> • Ability to work under pressure and meet deadlines </div> <div> • Ability to handle multiple projects at once </div> <bR> </tD> </tR> </TABLE></div> <div> <B><U>The Artac Seel Company</U></B></div> <div> --Effectively Delivering Talent in Pharmaceuticals & Biotech--</div> </td> </tr></table></body>