Director Safety Data Sciences

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 .

This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.

The position can be remote

Responsibilities:

• Responsible for oversight of surveillance and regulatory activities and deliverables in your designated Therapeutic Area (TA).
• Leads a team of Safety Data Sciences in their role on the Product Safety Team (PST) within a given TA; contributes to the benefit risk evaluation and to safety risk management.
• Provide oversight and actively manages full time employee (safety data scientists) and contract support personnel.
• Key collaborator with Therapeutic Area Heads, safety and clinical physicians and Data and Statistical Sciences to develop strategies for routine and ad hoc safety data analyses.
• Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures
• Utilizes medical judgment to determine the impact of the safety issue on the product's benefit-risk profile.
• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plans.
• Assure deliverable alignment to current company standards and global regulations for products/compounds assigned to direct reports.
• Leads safety-related activities/initiatives internal to PPS and with external partners.
• Independently prepares summaries of key safety data for PST, ADT, senior management, Advisory and other similar meetings.
• Trains new safety scientists and mentors established colleagues.

Qualifications

Basic:

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
  • Bachelors + 7 years clinical/pharma or safety work experience
  • Masters or doctorate + 5 years clinical/pharma or safety work experience (e.g. MPH, PharmD, or Masters in a Health Science)

• Knowledge of the drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
• Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.
• Understanding of tools, standards and approaches used to efficiently evaluate drug safety.
• Experience in working directly with and influencing senior management including functional heads
• Identifies strengths and weaknesses of team members to further develop their skills through training, mentoring and learning opportunities.
• Optimizes use of team resources and ensures quality and timeliness in team contributions.
• Prior experience with people management desired.
• Identifies new partnerships throughout Abbvie to increase efficiencies
• Initiates strategic plans for deliverables and leads process improvements
• Effective oral and written communication skills with the ability to manage multiple projects simultaneously
• Microsoft WORD and EXCEL skills and Basic Project Management skills
• Able to work independently seeking guidance from manager and PST leads and TA physicians as needed. Able to problem solve and anticipate problems.

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