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Manager, Drug Safety

Hyperion Therapeutics

Location:
South San Francisco, CA
Posted Date:
7/2/2014
Position Type:
Full time
Job Code:
Manager, Drug Safety
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Drug Safety, Manager,

Job Description

Position Purpose
The Drug Safety Manager is responsible for the collection, safety review, processing, and reporting of adverse event data for clinical trials and marketed products in compliance with applicable FDA and global regulations.  This position will assist with the establishment of operational procedures and departmental compliance with those procedures. The position manages the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other Hyperion business areas. The manager assists in providing proactive safety surveillance across the lifecycle of products. This position Reports to the Director, Drug Safety & Pharmacovigilance.
Principal Responsibilities
•   Process and assess AEs from receipt to case closure in the Hyperion Argus Safety Database including narrative and ASE writing
•   Conducts clinical and post marketing follow-up to complete needed AE information
•   Ensure proper QC of ICSRs
•   Oversee and ensure timely and accurate processing of individual reports and safety reporting to regulatory authorities, investigators, and business partners within the required timelines
•   Develops/updates Standard Operating Procedures and Working Instructions for department and ensures staff compliance
•   MedDRA coding of SAEs and AEs as reported in source documents of AE reports, ensuring consistent data categorization
•   Drafting and/or contributing to drug safety documents, including but not limited to Safety Management Plans for clinical studies and safety exchange agreements with licensing partners
•   Drafting and/or contributing to FDA and global periodic safety reports
•   Review and reconcile SAE data for reconciliation between clinical and safety databases
•   Member of study management team for assigned study protocols; Interacts regularly with Clinical Operations, Medical, Regulatory Affairs, and Data Management groups
•   Coordinates and participates on projects for safety signal detection, safety analysis, and Pharmacovigilance
•   Provide guidance/oversight to junior staff members for all drug safety/pharmacovigilance activities
•   Remains informed of all appropriate current FDA, EMEA and related regulations and guidance, including those from ICH
•   Maintains and updates documentation of personal training records

Requirements

•   Science (BS/MS) or Health care professional (PharmD or RN degree) or equivalent
•   5+ years of relevant experience in a pharmaceutical or biotechnology company Drug Safety Department
•   Excellent understanding of drug development, Drug Safety reporting, FDA and International Regulations for adverse event reporting, and working knowledge of the importance of regulatory compliance
•   Strong computer and database skills, experience with Drug Safety databases; ARGUS database experience a plus
•   Strong organizational, oral/written communication and project management skills
•   Requires attention to detail and a high commitment to the quality of all projects and accountability for deliverables
•   Demonstrated ability to manage multiple projects and prioritize
•   Ability to solve complex problems and suggest creative solutions
•   Proactive, positive approach to work projects and constructive, supportive interactions with colleagues

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