Medivation, Inc. (NASDAQ: MDVN – www.medivation.com), a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Drug Safety Manager, an individual contributor role.

The company is currently focused on three programs in late stage clinical development, targeting large, unmet medical needs.  Dimebon is in two global Phase 3 trials in Alzheimer’s and Huntington disease.  The company’s second compound, MDV3100 is in two global Phase 3 trials in castration-resistant prostate cancer.

Job Description:
The Manager of Drug Safety will independently support the Drug Safety Department.  The Manager of Drug Safety will work in a role of leadership in development, implementation and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance and metrics.

Responsibilities:

The major duties and responsibilities will include but are not limited to:

• Process SAE and AE reports of marketed and investigational products in accordance with all applicable regulations, guidelines, and SOPs with little or no supervision.  This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.
• Maintain regulatory and department compliance by ensuring timely completion of reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, licensing partners and CROs.

• Represent the Drug Safety Department in cross-functional team meetings.
• Conduct periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.
• Participate in the preparation of aggregate safety reports, such as quarterly safety reports to Ethics Committees and annual reports to regulatory authorities.
• Draft and update departmental SOPs and other work practices as assigned and maintain consistency with regulatory guidelines and good pharmcovigilance practices. Participate in regular audits of department SOPs.
• With guidance from the (Director), participate in training of drug safety staff and internal and external audiences on drug safety related topics, such as investigator meetings.
• Evaluate project case workflow and offer solutions for process improvement.
• Maintain a high level of understanding of federal and international regulations and guidances so as to guide departmental policies and procedures.
• Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates and Senior Associates, to facilitate efficient case processing.
• Provide mentorship to DSAs and Senior DSAs in day to day case processing activities.
• Draw upon the knowledge of Drug Safety regulations & practices, disease specific clinical knowledge and understanding of corporate objectives to solve complex problems in creative and effective ways as well as to anticipate routine problems and mitigate them without supervisory intervention.

Requirements:

• Typically requires a BS degree in a life science discipline, e.g., pharmacy, nursing, and a minimum of 6 years of relevant experience which includes 4 years in drug safety.

• Broad knowledge of domestic and international drug safety regulations, industry practices and standards
• Must have a strong attention to detail, teamwork and initiative
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills
• Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
• Proficient in Microsoft Word, Power Point and Excel

Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V