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Job Field: Environmental Jobs
Location: South San Francisco, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Medical Director, Pharmacovigilance & Risk ManagementDrug Safety | South San Francisco, CA, United StatesSummary:  Provide strategic leadership and medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products of Onyx Pharmaceuticals, Inc. Oversee the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of all Onyx products. Ensure successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company&rsquo;s business strategy, industry standards and compliance with global regulations. This role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues from Clinical Science, Clinical Operations, Biometrics, Project Management, Regulatory & QA, MedSA, Commercial, IT, Finance and Legal.Essential/Primary Duties, Functions and Responsibilities:* Perform individual case safety assessments of causality, expectedness and seriousness of all reported clinical trial and post-marketing safety reports, and clinically approve all potential expedited reports to global health authorities.* Conduct evaluation of other relevant safety information, such as from non-clinical studies and product quality complaints.* Ensure accuracy and timeliness of expedited and periodic reports from clinical trials and post-marketing safety surveillance.* Responsible for the identification, analysis and reporting of possible trends and concerns with Onyx products, including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate trend analyses and review of relevant literature for safety information pertinent to product safety.* Chair meetings of a multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations to the global labeling team for safety issues, as deemed appropriate.* Collaborate with Regulatory Affairs and other functional areas to design, implement and oversee risk mitigation strategies (REMS, Risk Management Plans, and Post-Marketing Evaluation Programs) to ensure the safe and appropriate use of Onyx products, in compliance with global legal and regulatory requirements.* Participate in multidisciplinary product labeling discussions for updates to core data sheet and local product labels.* Own and directly oversee the content, management and timely submissions of medical safety documents (i.e., periodic reports, annual reports, periodic safety updates, safety signal work-ups, pharmacovigilance plans, risk management plans, risk-benefit assessments, etc.) for assigned products.* Provides input and review to key regulatory or clinical documents (i.e., protocols, statistical analysis plans, clinical study reports, investigator brochures, integrated summaries of safety), as appropriate, to ensure that they are of high medical and scientific quality.* Participate in various program-related and company governance bodies, contributing to the global strategy and clinical development plans for Onyx products from a safety perspective.* Establish effective working relationships with medical leaders in Clinical Development and Medical Affairs organizations, as well as their counterparts at partner companies.* Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Pre-Clinical, Legal, Manufacturing/Quality, Medical Affairs, Commercial and other functional areas to align on a harmonized approach to identifying, evaluating and communicating safety issues.* Collaborate with pharmacovigilance and drug safety colleagues from global partners.* Lead negotiations with business partners relating to global pharmacovigilance agreements.* Ensure effective communication in safety matters, both potential and known, with VP, Pharmacovigilance & Dr

KEY REQUIREMENTS:

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Not stated