Senior Pharmacovigilance Operations Specialist/Manager

Clinical Development · San Diego, California
Department Clinical Development
Employment Type Full Time

Xencor is an innovative, clinical-stage biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Senior Pharmacovigilance Operations Specialist / Pharmacovigilance Operations Manager to join our team. 

Our capabilities and the modular nature of our technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific technologies, and seven XmAb bispecific antibody programs are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing in the United States.

Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.

Job Duties include:

• Assist in oversight and management of a Safety CRO.

• Serve as a point of contact between Drug Safety Operations and the Safety CRO regarding cases content, tracking and quality.

• Provide and communicate regularly with Safety Service Provider and develop quality ICSR case processing and reporting metrics. 

• Oversee SAE reconciliation. 

• Contribute to solving reconciliation coding issues/discrepancies.

• Contribute to the resolution of issues from cases of high complexity through medical / safety expertise and leading team interdepartmental interactions.

• Perform quality review of vendor case processing activities in line with Drug Safety processes and procedures, and recommend corrective actions, if required

• Conduct evaluation of other relevant safety information (e.g. from non-clinical studies and other departments) as required

• Assure required safety submissions are of highest quality and submitted within regulatory timelines, including SUSARS, DSURs and additional ad hoc safety reports.

• Perform other drug safety operations tasks as determined by the needs of Drug safety and PV department.

• Support PV MD in signaling activities and Literature reviews.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Requirements/Qualifications:

• At least 3-5 years relevant pharmaceutical industry experience/expertise, with significant previous experience in pharmacovigilance in an operational position

• Healthcare or clinical training (RPH, PharmD, RN or other relevant graduate degree) desirable

• Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure

• Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environments

• Demonstrated expertise in Argus safety database

• Ability to triage SAEs, QC SAE cases, and write ICSR narratives 

• Proven ability to strategically apply principles of clinical assessment of adverse events in the pharmaceutical industry

• Knowledge of MedDRA dictionary with relevance to adverse event coding

• Strong analytical, assessment and problem-solving skills

• Demonstrated ability to read, analyze and interpret clinical data and information

• Excellent interpersonal skills and professionalism.

Physical Demands:

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.

We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development.  With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume.  For further information about Xencor, please visit our website at www.xencor.com   EOE

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement.

Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.

 

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  • Location
    San Diego, California
  • Department
    Clinical Development
  • Employment Type
    Full Time