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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>Associate Director, Pharmacovigilance & Drug SafetyDrug Safety | South San Francisco, CA, United StatesSummary / Overall PurposeThe Associate Director, Pharmacovigilance and Drug Safety position encompasses a key role in setting and executing on departmental strategy, as well as managing the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Oversees all departmental activities associated with both investigational and marketed products.  This role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues from Clinical Science, Clinical Operations, Biometrics, Regulatory & QA, MedSA, Commercial, IT, Finance and Legal.Essential/Primary Duties, Functions and Responsibilities:Adverse Event Case Management Responsibilities:* Ensure that all safety reports received from any source (clinical trials and post-marketing) are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.* Perform Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database* Ensure that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate* Liaise with assigned Physicians in Drug Safety, Clinical Science and/or MedSA to ensure that appropriate medical review and assessment is provided for assigned case reports* Manage communications with partner companies, collaborative sponsors & respective CROs regarding the evaluation & processing of case reportsAdditional Safety Management Responsibilities:* Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems.* Assist Medical Directors in the analysis, identification, and reporting or possible trends and concerns with Onyx products, including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.* Manage the planning and preparation of the adverse events section of protocols for Onyx clinical studies, review of paper and/or electronic CRFs, and investigator meeting presentations* Assist in the negotiation of safety exchange agreements with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission. * Manage activities for Investigator Sponsored Trials (ISTs), including review of protocols, review of IST contracts, and appropriateness of safety data received from IST trials. * Participate in the development and management of Data Monitoring Committees, including development of DMC Charters and QA/QC of required line-listings and aggregate summaries of ARISg safety data* Ensure that the reconciliation of ARISg safety data with groups external to Onyx Drug Safety (e.g., Data Management staff for clinical studies, Drug Safety personnel from partner companies, etc.) occurs according to Onyx SOPs* Participate in Product Development team (PDT), Study Execution Team (SET) and similar meetings, representing the Drug Safety department* Oversee the preparation of ASURs, DSURs, IND Annual Reports, PSURs and other global periodic safety reports* Participate in the development and review of appropriate safety sections of IBs, CSRs, ISS, NDAs.* Manage the process for identifying, evaluating, and selecting outsourcing vendors (e.g., CROs, Call Centers, safety database vendors)* Ensure training of appropriate Company personnel and external groups in pharmacovigilance and drug safety principles, policies, and SOPs* Review aggregate safety data from the clinical database in support of Data Monitoring Committee meetings, interim analyses or final database lock.* Collaborate with pharmacovigilance and drug safety colleagues within global Partners* Ot

KEY REQUIREMENTS:

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