DIRECTOR REGULATORY AFFAIRS, DRUG SAFETY& SURVEILL

Our client is a multi-national specialty pharmaceutical company, with core competencies in development of late stage drugs and marketing of pharmaceuticals and delivery devices.  We are pleased to present the following opportunity


 DIRECTOR REGULATORY AFFAIRS, DRUG SAFETY& SURVEILLANCE is a senior level position within Medical Affairs reporting directly to the Director Medical Affairs. 
• has management responsibility for the Regulatory Affairs Associate, Worldwide Drug Safety & Surveillance, and may provide direction and guidance to staff members assuring GCP and GLP compliance



RESPONSIBILITIES: 
1.  MANAGE THE PROCESS FOR INDIVIDUAL CASE SAFETY REPORTING FOR PRODUCTS IN DEVELOPMENT, MARKETED PRODUCTS, REGISTRIES AND LITERATURE CASES: 
2.  MANAGE PERIODIC SAFETY UPDATE REPORTING: 
• Support the preparation of IND and NDA annual reports for the US
3. ASSURE THAT PROCESSES ARE DEFINED
4. ASSURE DETECTION AND ANALYSIS OF POTENTIAL ADVERSE EVENT SIGNALS AND CHANGES TO THE RISK PROFILE: 
• Perform Product Safety Risk Management and conduct on-going safety signal detection, development and/or update each product’s Safety Specification and Pharmacovigilance Plan document and Risk Minimization Action Plans.
5.  MANAGE PROPOSALS FOR LABELING CHANGES: 
• Manage bringing local labeling implications into the Risk Management assessment process as new benefit-risk data, pharmacovigilance trend analyses, and changing paradigms of medical practice may impact the need for labeling changes. 
6.  REVIEW GLOBAL DRUG SAFETY LEGISLATION/GUIDELINES, AND IMPLEMENT PHARMACOVIGILANCE PROCESSES TO MEET ALL REQUIREMENTS (INCLUDES MONITORING CURRENT AND PROPOSED REGULATIONS):. 


7.  MAINTAIN AND UPGRADE THE ELECTRONIC ORACLE AERS INFORMATION SYSTEM, OR DESIGN AND IMPLEMENT SYSTEM ALTERNATIVES IF SELECTED: 
• MedDRA and WHODRUG dictionary version upgrades,
 
 KNOWLEDGE AND SKILLS:
• Education:  MS in scientific field, and/or knowledge of epidemiology
• 5 years or more in pharmaceutical company
• Prior experience in managing direct reports a plus
• Working Skills and Competencies Trained in use of an electronic pharmacovigilance system and capable of translating electronic submission requirements into operational directions and/or implementation; experience specifically with AERS a plus
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