Associate Director, PV Systems
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
The Associate Director, PV Systems provides support and supervision of the development, configuration and maintenance of key databases and systems utilized by Global Patient Safety & Epidemiology (GPSE). These systems include the Global Pharmacovigilance & Product Complaints (GPPC) database, (i.e., Argus Safety /Argus Affiliate, Business Objects), and other systems and tools that support Global Patient Safety & Epidemiology's mission of monitoring and reporting patient and product safety, including E2B gateway, Literature tracking tool, Safety Information and Reporting tool and signal detection tool, PV Agreements tool, Risk Management Activities System, Signal and ad-hoc query Tracking And Reporting Tool and Corrective and Preventative Action tool.
- Extensive experience in safety reporting utilizing Argus Reports and Business Objects (or OBIEE) is required, along with the ability to provide expert liaison support to report owners, with the ability to translate user requirements into report functionality.
- Significant interaction with vendors, Research and Development Information Technology ( RDIT), report owners inside and outside GPSE with the ability to provide excellent customer support is key to the successful candidate. Argus-J experience is desirable, but not required. Ability to build advanced queries and perform data extraction for routine and ad-hoc analysis is essential.
- Other responsibilities may include the preparation and maintenance of user guides and training materials, maintenance of select business configuration in GPPC, participation in IT projects including user acceptance testing and coordination of database change activities. Provide support for regulatory inspections and audits.
- The Associate Director of PV Systems may serve as the designated back up for Director, PV Systems.
- The employee is expected to be fully capable of performing roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. Thus, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization.
- The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, CFR and ISO guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
- BA/BS in life science, computer science or equivalent required
- Six+ years of experience in drug safety / pharmacovigilance, including both investigational and marketed products
- Knowledge and experience with pharmacovigilance safety database (e.g., Argus/ARISg) including retrieval and navigation skills and electronic exchange gateways (eg Axway) required.
- Experience and proficiency with use of ad-hoc database reporting tools (e.g., Business Objects, Cognos, Spotfire, or equivalent) advanced conditions is required
- Experience with Argus-J and MedDRA-J or other Japanese safety system and dictionary (desirable)
- Project management experience
- Experience with collection and reporting of Serious Adverse Events (SAEs) associated with investigational drugs (i.e. SAEs from Clinical Trials) as well as all AEs from post-marketing sources
- Experience with exchanging safety data with Associated Business Partners or affiliates
- Good understanding of Good Clinical Practices, ICH guidelines, FDA CFR, EMA, ISO, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
- Good understanding of pharmacovigilance including Good Vigilance Practices, Drug Safety processes, standards, conventions and governance
- Proficiency with electronic systems including Office 365 and collaboration tools (e.g. Sharepoint and Teams)
- Excellent written and verbal communication and interpersonal skills
- Ability to work effectively on multiple projects under tight timelines, maintain flexibility, adapt, and prioritize as required
- Ability to work independently at the regional or global level with remote or minimal supervision
- Ability to lead teams in matrix environment
- Strategic thinking, planning, organizational, project management
- Customer Service Orientation
- Ability to travel at least 5-10% of time
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.