Maintains oversight of all required PV regulatory reporting compliance in a timely manner. Provides comprehensive compliance metric reports to the Medical Director to ensure full visibility of compliance issues, at least quarterly.
Advises the business on the PV impact of local ODC programs (e.g. patient support programs).Escalates compliance issues in a timely manner to Affiliate Vigilance Excellence and the Medical Director to ensure appropriate mitigation is implemented.
Monitors and forecast PV workload to identify, mitigate, and escalate potential PV resource and non-compliance issues.
Identifies periods of high PV workload and manages PV resource appropriately to address them.
Develop, manage, and implement quality principles to ensure effective compliance of the affiliate quality system with Abbvie policies, processes and procedures and all applicable regulations and industry standards including establishment and maintenance of local procedures, work instructions, records and all applicable quality system documents.
Coordinate and investigate quality events such as deviations, nonconformities, complaints and corresponding action plans including decisions to assure continuous improvement of product and quality systems.
Overlook affiliate label finishing activities (e.g. overlabeling, redressing) to ensure compliance with requirements and minimize risk.
Manage internal and external quality inspections and audits (including reporting response to observations and tracking of actions / plans.
Quality management of supplier qualification program for the affiliate including audits, quality agreement and performance monitoring.
Quality management of medical devices.Coordinate and support of all activities related to product action (recalls, withdrawals, corrections, etc) in the affiliate.
Coordinate the Management Review process for the Affiliate.
Coordinate quality training program; develop / implement quality system training to insure compliance with identified quality goals / standards and that promotes highest level of quality and compliance.
Responsible for establishing / carrying out a quality self-inspection program within the affiliate.Coordinate with internal / external customers on all quality / compliance-related matters.
Represent affiliate QA in regional, global and cross-functional teams, programs / projects as assigned by management.
Ensure training of affiliate staff on relevant Quality Assurance processes. Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPS and local regulations.
Maintains compliance with local agreements, including reconciliation between partner companies. Ensures a local tracking system is in place to monitor compliance to local safety data exchange timeframes.
Reviews all risk management plans to obtain information on the risk / benefit profile of products.
Medical, pharmacy or life-sciences degree (or equivalent.
Minimum of two years' experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Affiliate Safety Representative role but is less critical for the backup ASR role.
Demonstrated attention to detail. Excellent written and spoken communication and presentation skills.
Fluency in written and oral English is highly desirable in order to facilitate communications with Global Pharmacovigilance, Regional Medical and other headquarters functions.
Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority.
High customer orientation.
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
Sound judgment, strong planning and organizational skills, and the ability to get things done.Demonstrated strong sense of urgency.
Travel : No
Job Type : Experienced
Schedule : Full-time
Job Level Code : IC
Equal Employment Opportunity Employer
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.