Position?Purpose
Individual?filling?the?position?are?responsible?for?the?project?management?of?safety?aggregate?reports?submitted?to?regulators?that?include?the?FDA?and?EMA.??The?incumbent?will?partner?with?various?colleagues?from?safety,?clinical,?regulatory?and?other?functional?lines?to?produce?the?aggregate?reports?and?ensure?that?these?reports?are?completed?in?a?timely?manner?meeting?regulatory?compliance.
Primary?Responsibilities
? Lead?report?preparation?from?prep?to?submission?with?key?stakeholders/contributors?within?Clinical,?Regulatory,?Safety,?DevOps,?Submissions,?etc.
? Review?data?to?ensure?consistency?between?various?contributors.
? Compile?the?information?for?reports?using?various?electronic?tools?and?document?management?system.
? Coordinate?the?review?and?approval?of?the?report?and?address?review?comments.
? Ensure?reports?are?completed?prior?to?regulatory?due?date?to?meet?compliance.
? Provide?guidance?to?contributor?regarding?report?requirements.
? Participate?projects?or?subject?matter?tasks?that?support?the?group?and?deliverables.
? Participate?in?developing?and?performing?User?Acceptance?Testing?(UAT)?as?required.
? Complete?training?in?accordance?with?Pfizer’s?and?WSR?Safety?information?Management?curriculum.
Technical?Skill?Requirements
? Experience?in?the?pharmaceutical?industry,?clinical?research,?or?healthcare?related?field.
? Experience?with?Microsoft?word?&?excel,?Adobe?acrobat,?ISI?Toolbox,?etc.
? Experience?with?SharePoint?technology?(e.g.,?Microsoft?InfoPath,?SharePoint?Designer,?etc.)
? Business?Objects?experience?is?a?plus.
Qualifications?(i.e.,?preferred?education,?experience,?attributes)
? Bachelor’s?Degree?in?life?sciences,?healthcare,?or?pharmaceutical?discipline?required.
? Excellent?English?verbal,?written?communication?and?presentation?skills?required.
? Must?be?detailed?oriented.
? Strong?project?management?and?issue?resolution?skills?required.
? Demonstrated?ability?to?perform?in?a?cross-functional?environment.
? Knowledge?of?regulatory/safety?regulations?and?guidelines?desired.
