Description
Essential Function* Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
* Ongoing safety surveillance and signal detection/analysis
* Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
* Provide medical input in all required safety reports, such as -but not limited to - PSURs, Clinical Expert Statement, Investigator notification letters
* Review all documents assigned for scientifically relevant issues including drug safety
* Function as pharmacovigilance representative/safety leader/senior technical lead on the projects, in Proposal Development Team and/or client meetings
* Provide medical advice and support for the safety component of feasibility studies
* Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
* Support of Medical Directors as required
* Support of the QPPV
Key Accountabilities
* Medical and scientific Pharmacovigilance review of:
-Literature Reports including epidemiological background research
-Clinical trial reports
-Study protocols
-Clinical Trial (Serious) Adverse Event Reports
-Post-marketing ADR reports
-Case files, narratives, coding, causality and expectedness assessment
* Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
* Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
* Provide medical guidance to Safety Staff during the case processing cycle
* Review and sign off technical documents written by company with respect to medically relevant matters with particular attention to those relating to drug safety
* Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
* Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
* Participate in Proposal Development Teams (PDTs) for client bid meetings
* Maintain up-to-date knowledge of projects by attending Professional Society Meetings
* Provide support for marketing activities as requested
* Provide medical safety expertise to client per request
* Provide medical safety expertise and training to other personnel, as required
* Be able to provide a 24 hours/day, 7 days/week availability per request
* Maintain a current medical license.
* Keep current with professional and pharmacovigilance regulations and knowledge
* Accommodate Pharmacovigilance timelines through flexible approach to working hours
Qualifications
* Experience in Pharmaceutical Medicine desirable
* 1-2 years of PV experience preferred
* Clinical practice experience desirable
To find out more about Real please visit www.realstaffing.com