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Job Field: Security
Location: South San Francisco, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Id : 32707Date Created : 11/1/2012 5:52:44 AMLocation/City : CA - South San FranciscoJob Type : ContractRecruiter Name : Jeff SimeoneRecruiter Email : jeff@ccsiinc.comSafety Science Leader - Research - Discovery - 3554851Location: South San Francisco, CALength: 1 YearIf interested, please send resumes to Jeff@ccsiinc.comDescription:? Contributes to scientific publications (abstracts,posters, papers) forscientific meetings/journals and approves submissions from a safetyperspective.? Reviews all communications to the public from a safety point ofview.? Keeps the EU QPPV fully informed of any changes to the benefit-riskrelationship and, where appropriate, performs tasks as delegated bythe EU QPPV.? With the CSL and the DST, plans and performs, on anongoing basis,an evaluation of the safety data to detect safety signals. On an ongoingbasis with the team, evaluates the Benefit/risk relationship oftheprogram and determines how to manage patients within and acrosstrials.? Is accountable for safety components of all NDAdocuments.? Is responsible for the writing and maintenance ofRMP/REMS NDAdocuments.? Represents Roche in interactions with HealthAuthorities andIndependent Data Safety Monitoring Boards (ie Pre-BLA/NDAmeetings,advisory committees) for safety related topics.? Contributes to and where specifically delegated maybe responsiblefor the proper execution of the post-approval RMP/REMS? Ensures that all safety processes are properlysupported andcompliance is documented for all studies conducted by PD or PBor affiliates.Skills:? Significant period of time in clinicalpractice? Significant experience with drug developmentincluding theevaluation and interpretation of scientific and clinicaldata.? Demonstrated knowledge of Safety Science across abreadth oftherapeutic areas particularly in relation to issue managementandsignal detection and evaluation.? Solid knowledge and understanding of US and EUpharmacovigilanceregulatory requirements and general regulatory expectations? Proven experience in proactively leading a team ofindividualspotentially located across a number of sites and leading themtooptimize their performance and contribution.? Ability to interact with Health Authorities as theprimary contactperson for safety aspects in face-to-face meetingsEducation:MD or equivalent.Clinical practice experience strongly desired.Previous bio-pharmaceutical industry experience strongly desired, especially in Drug Safety/Pharmacovigilance.

KEY REQUIREMENTS:

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Not stated