Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.
Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated. We are proud to be an equal opportunity employer who respects individual differences and recognizes each employee as an integral member of our company. Our culture is one where everyone can learn and develop personally and professionally.
This is an opportunity for a Director in the Medical Safety Review Team (MSRT) within GRAAS (Global Regulatory Affairs and Safety) Operations and Quality Management. The purpose of this group is to provide medical review of individual safety case reports in support of safety surveillance for Onyx/Amgen products and to support global individual case safety regulatory reporting compliance.
This global role may have direct reports, but spends more than 80% of time working as an individual contributor.
Ensures successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company’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 Therapeutic Area Safety, Clinical Science, Clinical Operations, Biometrics, Project Management, Regulatory & QA, MedSA, Commercial, IT, Finance and Legal.
Safety Management Responsibilities:
* Execute medical review of specific SAE and PMAEs for clinical content.
* Ensures accurate medical coding (MedDRA and WHO-DD) of safety data
* Execute medical triage for appropriate causality assessment on ICSRs for regulatory reporting.
* Execute ICSR case escalation to Global Safety Officer.
* Support AE evaluation including triage and case follow-up measures by case processing.
* Support creation of follow-up queries per due diligence measures.
* Support medical coding conventions, data collection methods, and systematic process improvements for AE processing.
* Execute review of ICSRs for clinical trial safety data and escalate possible safety issues to Senior Management as required.
* Support safety PV processes for Onyx/Amgen products.
* Participate in EOI management strategies.
* Support Risk Management Plan implementation and evaluation as needed.
* Support development of strategies for compliance with global regulatory authorities’ requirements.
* Act as a TA-based liaison (Product Lead) for Onyx / Amgen functions on SAE and PMAE case management (Legal, Licensing, Operations, Marketing, etc.).
* Facilitate development of productivity and compliance metrics for AE processing for MSRT.
* Support development of a global safety function at Onyx/Amgen with a singular voice on worldwide safety issues.
* Facilitate/advise on SOP/eMAN creation.
* Participate in AGS GST and Global Safety meetings.
* Expand clinical expertise in other therapeutic areas to promote flexibility and efficiency.
* Help hire, manage, mentor and develop AGS staff.
* Advocate and actively support Regulatory/Safety compliance.
* Active participant in multidisciplinary Safety Management Teams whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations to the global team for safety issues based on expertise in ICSR review, as deemed appropriate.
* Participates as requested in multidisciplinary product labeling discussions for updates to core data sheet and local product labels
* Participates in various program-related and company governance bodies, contributing to the global strategy and clinical development plans for Onyx products from a safety perspective.
Departmental and Line Management Responsibilities:
* Assists in the preparation of departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of Onyx /Amgen products.
* Monitors industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommends changes and upgrades to existing departmental policies, SOPs and systems.
* Participates in due diligence teams to evaluate new potential in-licensing and out-licensing opportunities
* Medical Qualification (DDS/DMD, MD/DO or international equivalent) plus a minimum of 3 years relevant work experience in a clinical patient setting
* 3-5 years of relevant pharmaceutical industry experience/expertise with >2 years in pharmacovigliance, with both pre- and post-marketing experience.
* Demonstrated mastery of global regulatory requirements for pharmacovigliance.
* Clinical knowledge of therapeutic area patient populations and drug class.
* Proficiency in technical safety systems including safety database and medical coding.
* Mastery of safety data capture in clinical trials and post-market setting.
* Knowledge of clinical trials and drug development.
Management of Staff:
* Proven ability to effectively manage direct reports and mentor talent
Functional/Technical Knowledge & Skills:
* Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
* Extensive knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry
* Expertise in MedDRA dictionary with relevance to adverse event coding
* Experience in working with software based drug safety systems, preferably the ArisG safety database.
* Strong computer skills (MS Office)
Customer & Industry Knowledge:
* Advanced knowledge of domestic and international safety regulations, Good Clinical Practices, principles of drug development and safety assessment of marketed and investigational drugs
* Drug safety review experience of 2 years or more.
* Drug safety database experience
* 3-5 years of industry including safety experience preferred
* Residency training or significant clinical experience in relevant therapeutic area
* 2-5 years of clinical experience including training.
* Masters level degree (MPH, MS, MBA or equivalent) preferred
* Specialization and/or experience in oncology or hematology preferred.
* Current Active Medical License preferred >25 CME per year for previous 5 years
* Board certification or board eligibility preferred
* Outstanding communication skills (verbal and written), including formal presentation skills
* Strong, demonstrated decision-making, organizational, prioritization and problem-solving skills
* Strong analytical, assessment and problem solving skills.
* Outstanding interpersonal skills and professionalism
* Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
* Advanced ability to read, analyze and interpret clinical data and information
* Demonstrated ability to establish effective and collaborative working relationships with people in a wide variety of disciplines and backgrounds
* An expert in managing and prioritizing multiple projects and demands simultaneously, with ability to rapidly adjust to changing priorities and work effectively under pressure
* Ability to travel both domestically and internationally (<25%)
Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.