About AbbVie
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.

For our office in Wiesbaden we are searching for

Pharmacovigilance Manager (all genders)

 

Primary responsibilities

• Supports the Pharmacovigilance Leads in all aspects of role and responsibilities

PV System Oversight:

• Prepares PV metrics to enable oversight of all aspects of the performance and functioning of the PV system
• Monitors compliance with local regulations, internal company timelines and standards
• Oversees vendor compliance (e.g. reconciliation, reporting timelines etc.)
• Supports the surveillance of partner/service provider compliance
• Oversees and implements actions in case of non-compliance

Quality Management System:

• Supports in implementation and maintenance of the quality system, including:

• Maintains/creates formalized local PV procedures that are in line with global requirements and local legislation, with appropriate quality control measures
• Determines training need within the PV department and informs stakeholder upon creation or update of formalized local PV procedures
• Oversees the impact assessment of global Standard Operating Procedures (SOPs)
• Manages issues in line with the Pharmacovigilance (PV) Corrective and Preventive Action (CAPA) process including timely notification
• Manages planned deviations
• Implements mechanisms to enable continuous process improvement
• Performs business continuity plan testing
• Oversees reachability of relevant functions  during out of office hours
• Coordinates content test calls for relevant functions

Audit & Inspections:

• Supports internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV inspections
• Supports the development of CAPA in response to observations and tracks actions to completion in a timely manner

Individual Case Safety Report (ICSR) responsibilities:

• Reviews and maintains the local list of journals included in the local literature screening according to global requirements and local legislation
• Performs quality control of data entry (including follow up) of locally received high impact cases (e.g. pre-approval programs)

Therapeutic Area Interface:

• Acts as local Subject Matter Experts (SME) regarding PV aspects for a specific Therapeutic Area
• provides training to Medical Science Liaison (MSL) and sales force
• supports Marketing Brand team in PV related inquiries, tasks and projects
• Provides safety topic related analysis and insights to the respective Medical Team
• Provides input to safety aspects and background to the respective Affiliate Risk Management Team

Medical Research Support:

• Contributes to contract and medical research document creation and implementation 
• Ensure that PV requirements will be implemented in all Non-interventional studies (NIS)/Post-marketing observational study (PMOS) and Investigator-initiated studies (IIS)  review of study protocols and reports
• Will perform every PV related task if necessary to ensure compliance

Qualifications

 

Skills

• Quality mind-set
• Global view/mind-set
• Good communicator/influential
• Excellent organizational and analytical with attention to detail
• Ability to identify, manage and escalate issues in a timely manner
• Process and operational excellence

Education / Knowledge

• Academic and/ or professional scientific background
• Advanced life-science degree (e.g., M.S., M.B.A., PharmD.) preferred
• Read, write, and speak fluent English and the local language

Experience

• Minimum 3 years of PV experience
• Understanding of PV case processing, medical terms, and medical causal relationships
• Broad PV systems knowledge
• Thorough knowledge of local / regional / area legislation and guidance (clinical trial, pre- and post-marketing)
• Knowledge of ICH and other major legislation/guidance (e.g. EU, WHO, CIOMS)
• Change management
• Knowledge of root cause analysis principles

 

Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.