Safety Specialist II, Pharmacovigilance & Epidemiology

Job Description

Specific Education & Experience Requirements:
Operations
BS degree in a life sciences field and little to no experience.
2+ years of experience in the drug safety field as a coordinator or similar role.

Medical Safety Coding (MSC)
4+ years related experience
Related life science or pharmaceutical experience permitted in equivalent substitution for education

Specific Job Responsibilities:
Operations
Sets work priorities and direction with input from Manager.
Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products.
Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Review, enter, and verify follow-up information for cases and make accurate determination of significant information
Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative
Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries.
Have basic working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports
Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably.
Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.e., obtaining clarification or follow-up information).
Identifies issues/concerns in a timely and appropriate manner
Meet specific data and quality targets for case handling
Remain current with case handling SOPs, guidance documents and database technology
Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.
Demonstrates general understanding of appropriate labeling documents for Gilead products.
Ensures departmental workflow processes and timelines are followed
Works with Submissions Team to properly identify global regulatory reporting requirements
May assist manager in the preparation of training material and assist in training new employees
May assist with other projects as necessary (i.e, study unblinding, clinical trial reconciliation, etc)
May identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist
May triage and assign the incoming reports.
May participate in some clinical trial activities with supervision from Manager or Sr Safety Specialist (i.e., protocol & CRF reviews, data management plan reviews, CRO agreements & flows)
Qualifications
Excellent interpersonal and communication skills, both written and oral
Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
Safety database and data entry experience preferred
Understanding of medical terminology and the ability to summarize medical information is preferred

Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
Demonstrates initiative, teamwork and accountability
Demonstrated success working both independently and in collaboration with others
A quality driven individual with strong attention to detail and accuracy is required
Strong organizational skills, and ability to adapt to change
A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required.
Ability to follow guidelines and procedural documents
Self-motivated and capable of working independently
Understands safety database structures and is familiar with data retrieval tools.
Case processing experience is preferred


Medical Safety Coding (MSC)
Works under minimal supervision.
Supports MSC Coding Group if assigned and ensures coding of adverse event and medication terms for clinical and post-marketing data using the MedDRA and WHO Drug coding dictionaries, and collaborates with Clinical Data Management (CDM) to ensure timely completion of coding jobs.
Maintains metrics log of MSC document reviews or coding jobs.
Generates reports from internal safety or coding database.
Provides functional group administrative support and assists in other projects as needed.
Demonstrates initiative in quality control of document archives and contributes to improvement of established processes.
Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point.
Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality.
Contributes toward completion of organizational projects and goals, and maintains meticulous attention to project deadlines.
Demonstrates wide range of knowledge in a number of specialized functions, with a high proficiency and understanding of both general and specific aspects of the job and their practical application to highly complex problems and situations.
Recognizes and seeks interdepartmental assistance for missing data; interdepartmental contacts are frequent and involve planning and preparation of communications, along with skill and tact to accomplish.