Sr Safety Spec, Pharmacovigilance & Epi
Sr Safety Spec, Pharmacovigilance & Epi
United States - New Jersey - Morris Plains
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Specific Education & Experience Requirements:
4+ years of systems analyst experience in the pharmaceutical industry preferably in Drug Safety
B.Sc. in a related life sciences field
Experience with BI tools is preferred
Health care professional degree (i.e. RN, PharmD) and 2+ years of drug safety experience or 1+ year of clinical practice experience
3+ years of drug safety experience and a BS degree in a life sciences field.
4+ years of experience in the drug safety field.
Medical Coding Safety (MSC)
6+ years related experience and a BS degree in a life science field (nursing, pharmacy, dentistry).
4+ years related experience and a MS/MA.
Related experience in life sciences or pharmaceutical industry may be equivalent substitution for education
Specific Job Responsibilities:
Independently establishes work priorities and direction with minimal input from manager.
Must be proficient in written and verbal communication.
Contributes to full life cycle of safety data retrieval activities -data query, authoring, validation and publishing reports.
Contributes to development of computer systems validation artifacts and executing validation protocols.
Demonstrates attention to details, teamwork and initiative.
Comfortable working with stakeholders to implement and support drug safety computerized systems in accordance with regulatory requirements and Gilead business practices.
Understands relational databases and reporting tools.
Knowledge of computer systems, data processing, and enterprise software applications.
Technical experience with computer systems, databases, and end user support.
Good working knowledge skills with Microsoft Office Products, Microsoft Visio, and Microsoft Project.
Understands current regulations within drug safety.
Independently establishes work priorities and direction with minimal 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 solid 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 and provides possible solutions.
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 especially for Gilead sponsored clinical trials reports
Organize training materials and train new employees in functional area
Perform clinical trial reconciliation independently
Oversee SAE reconciliations for multiple studies and set timelines for junior safety specialists.
Identify cases requiring investigator letters and draft investigator letters independently
Triage and assign the incoming reports.
Perform quality check of ICSR for junior staff members
Acts as a trainer and mentor for more junior staff members.
Responsible for DSPH input in clinical trial activities (i.e., protocol & CRF reviews, data management plan reviews, CRO agreements & flows)
Participates in Study Management Teams (as applicable)
Develop drug safety presentation for investigator meeting presentations.
May lead and manage functional projects or workstreams (e.g. monitoring CRO activities).
May serve as a point of contact to other functions in the organization or CRO's.
May have cross-functional exposure to ensure deadlines are met for specific projects.
May develop and/or assist with providing aggregate data review of quality checks for the PV Operations team.
May develop and/or assist with routine or ad-hoc reviews of processes or data entry conventions to ensure compliance with departmental SOPs and guidelines.
May assist with review of non-reportable cases with minimal supervision from Manager.
May serve as primary or back-up for Pharmacovigilance Responsible Person role and perform PRP duties as applicable
May particpate in assigned projects such as inspection readiness activities or inpection interviews
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 required
The ability to assess data and understand the medical/safety implications.
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
Demontrates 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 strick 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 required
Knowledge of clinical trials activities preferred
Ability to effectively represent PV Operations on multidisciplinary teams
Medical Safety Coding (MSC)
Participates as a member of the Core Coding Team, 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
Assists in special projects as needed.
Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point.
Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines.
Participates in determining objectives of assignments; plans, schedules, and arranges own activities in accomplishing objectives; work is reviewed periodically for adequacy in meeting objectives.
Demonstrates extensive understanding and application of principles, concepts, practices, and standards, with an advanced knowledge of industry practices.
Develops solutions to a variety of complex problems, and may refer to established precedents and policies.
Recognizes and seeks interdepartmental assistance for missing data.
Exerts some influence toward the overall objectives and long-range goals of the organization.
Interacts with internal and external personnel on significant matters often requiring coordination between organizations.
Represents organization as a prime contact on projects.
Works under general supervisory direction
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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