Amgen Pharmacovigilance Operations Senior Manager in Thousand Oaks, California

Amgen is seeking a Pharmacovigilance (PV) Operations Senior Manager who will join our Global Patient Safety team, and will work from Amgen's beautiful Thousand Oaks, CA campus.

The PV Operations Senior Manager will support proactive pharmacovigilance through consistent and accurate clinical data coding, development of dictionary queries to support safety data output generation, and monitoring of safety data exchange from the clinical trial database.

The PV Operations Senior Manager will be responsible for the following:

  • Manage the implementation and maintenance of standard Amgen coding dictionaries (MedDRA, WHOdrug) for Amgen Clinical Trials

  • Manage the processes for ensuring timely and accurate medical coding of study terms leveraging the MedDRA and WHODrug dictionaries

  • Manage the creation and maintenance of medically relevant dictionary coding search strategies, e.g. SMQ used for extraction of safety data from the clinical and safety databases by the Global Patient Safety product teams

  • Oversee the process for monitoring transmission of adverse events and related safety data to the global safety database

Key Activities

  • Provide Subject Matter Expertise on standard medical dictionaries and other relevant terminologies

  • Ensure all current medical terminology dictionaries are maintained, relevant data are up-versioned and clients trained on use

  • Proactively partner with cross-functional stakeholders in GPS&L, GDO, GBS and other relevant functions to develop consistent coding strategies and services

  • Provide input into the development of information and data management strategies

  • Manage the routine activities needed to support accurate and consistent transfer of safety data between the clinical and safety databases during study execution

  • Manage individual and group projects of moderate complexity

  • Manage the follow up on coding and/or safety data alignment activities necessary to support clinical database snapshots or locks during study closeout

  • Participate in the creation of standard process documentation and training materials (eg. SOPs, MANs Coding Guidelines) and ensure stakeholders are trained

  • Manage Amgen coding internal staff and external resources and budget

  • Manage the definition, collection and assessment of coding Metrics

  • Serve as the Business Owner for systems that support medical coding activities and collaborate with IS to define and implement system changes

  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

  • Supports inspection and audit activities, and the co-ordination of written responses to findings as required within remit of role

  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of experience in biotech/pharmaceutical safety industry

OR

Bachelor's degree and 5 years of experience in biotech/pharmaceutical safety industry

OR

Associate's degree and 10 years of experience in biotech/pharmaceutical safety industry

OR

High school diploma / GED and 12 years of experience in biotech/pharmaceutical safety industry

Preferred Qualifications:

  • Experience in safety databases

  • In-depth knowledge of MedDRA and WHODrug coding dictionaries

  • In-depth knowledge of Clinical Trial and Pharmacovigilance Processes

  • Understanding of clinical trial Electronic Data Capture (EDC) systems, clinical trial coding systems, and dictionary query management systems

  • Understanding of Safety systems (ARISg, Argus, or equivalent)

  • Understanding of software development lifecycle and development standards, including validation methodology

  • Understanding of global regulatory requirements for pharmacovigilance and safety reporting

  • Personnel Management/Vendor Management

  • Problem solving and process improvement experience

  • Organization, prioritization, planning and measurement of work deliverables

  • Ability to build relationships and work cross-functionally

  • Work independently and proactively; recognize and escalate issues

  • Computer skills (e.g., MS Office Suite)

  • Strong written and oral communication skills

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.