AbbVie

Executive Director, Medical Safety (MD)

Employer
AbbVie
Location
United States
Posted
Oct 14, 2020
Ref
203142
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Executive Medical Director - Medical Safety Physician is independently responsible for the proactive safety strategy and all medical safety aspects of pharmacovigilance and medical risk management for assigned development, marketed products and studies.

Monitors and manages the ongoing safety profile of products to maximize the understanding of risks and benefits for prescribers, patients, consumers and study subjects through proactive review of all relevant pre- and post-marketing safety data, medical analysis and decision making.

Activities include the oversight of safety aspects for clinical studies, development and maintenance of the Company Core Safety Information, development of ad hoc aggregate safety reports, contribution to and review of aggregate safety reports, development and conduct of signal detection activities and reports, safety sections of risk management plans, and review of field alert reports as appropriate, the assessment on patient impact for the health hazard evaluation (HHE).

Leads the Safety Management Team relevant to assigned products to determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects.

Collaborates with cross-functional teams and counterparts in regulatory labeling, clinical development, pre-clinical, manufacturing/quality, epidemiology, and other functional areas to identify, evaluate, and communicate safety issues.

Represents AbbVie in outside discussions, medical-scientific forums, at regulatory agency meetings, symposia and trade associations and establishes and maintains a strong network within the Pharmaceutical industry.

Other activities, special projects and assignments may be given as required. As a result, the percentage of time spent across roles for which the employee is responsible for, or assisting with, will vary depending on product and project assignments, current development projects and the requirements within the organization as a whole.

Conduct work activities in compliance with all relevant global regulations and guidelines as well as all AbbVie policies, and procedures. AbbVie policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

YOU ARE more than just a title, YOU ARE...

A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will
  • Lead the Safety Management Team (SMT) across the product lifecycle, the assessment of newly identified and potential risks for development risk management plans and risk minimization activities. Evaluate patient risk impact arising from deviations from product quality specification. Provide comprehensive recommendations on Risk Management strategies to Global Safety Board (GSB). Collaborates on authoring safety specification section of RMP and REMS documents and updates. Review and approve RMPs and REMS. In collaboration with relevant stakeholders evaluates effectiveness of risk minimization actions. Prepare safety statements for safety relevant communication purposes such as Dear HCP letters. Support product acquisitions, due diligence, legal issues and recalls, as appropriate.
  • Lead safety reviews and signal detection of assigned pre- marketed products. Review and approve signal detection activities for post marketed products. Make data-driven decisions and write safety review documents and reports. Determine resolution of signals. Evaluate and make recommendations on actions arising from signals in collaboration with the SMT. Escalate appropriate signals to GSB/CMO.
  • Participate in the preparation, review, approval, and distribution of the Development and Company Core Safety Information for inclusion in IBs, Company Core Data Sheets and local labeling. Participate in CDSRC meetings for CCDS development and updates/revisions. Reviews any significant proposed safety label changes to determine whether they constitute a deviation from the CCSI and initiate appropriate action. Update pre-marketing and post-marketing safety information and provide the justification documentation for any changes to IBs and CCSIs.
  • Be responsible for safety aspects of clinical trials including drafting and review of relevant safety chapters/text of key clinical trial documents such as informed consent, protocols (specifically inclusion / exclusion criteria and AEs of interest). Evaluate all safety data generated in clinical trials. Participate in global teams to provide medical safety leadership and development of risk management strategy. Liaise with assigned Data Safety Monitoring Boards. Respond to safety questions from investigator sites and IRBs regarding safety issues and queries. Provide medical safety interpretation of safety findings for all clinical study reports, including final review of safety relevant adverse event coding for assigned projects and discuss, propose, and communicate any revision(s) or additions. Ensure regulatory reports (e.g., clinical study reports, NDA, BLA) accurately reflect proper safety interpretation of the clinical study findings. Lead, author and own relevant sections of the development of clinical investigator brochures, integrated summaries of safety, risk/benefit assessments, clinical expert reports, and other relevant safety sections or documents in support of regulatory submissions and annual periodic or update reports. Lead safety response to health authority assessor questions after filing and response to Health Authority inquiries on clinical studies, when necessary.
  • Author relevant safety sections of aggregate reports (PSUR, PBRER and DSUR) and conclusions of product safety profile for these aggregate reports. Review and approve the aggregate reports. Contribute safety sections and risk/benefit assessment, if required, to Annual Safety Reports / IND annual reports. Review to ensure regulatory reports accurately reflect proper interpretation of findings. Assist in the preparation of safety sections and review of regulatory documents.
  • Lead recruitment and manage resources in therapeutic area. Identify and create development opportunities for staff. Prioritize work of direct reports. Train direct reports and new physicians. Ensure compliance with relevant policies and procedures. Assist with review of group performance metrics. Assist with resolution of complex, cross-functional issues. Contribute to the mentoring and on-boarding of new colleagues. Use the company performance management process to manage individual development. Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned product portfolio and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development. Develop inspection readiness for medical assessment activities and supports regulatory authority inspections when required. Represent AbbVie in outside discussions, medical-scientific forums, at regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Pharmaceutical industry. Liaise with internal and external experts / Key Opinion Leaders to obtain specialized medical expertise appropriate. Lead or contribute as an individual to projects / process improvements that support GPSE's strategic objectives.

#LI-PD1

Qualifications

You Bring
  • M.D. or equivalent
  • Specialized clinical experience in Ophthalmology
  • At least 8-10 years of experience in risk management and pharmacovigilance (safety signal detection, data mining techniques, pharmacovigilance databases, etc.)
  • At least 5 years of experience in safety monitoring in clinical trials
  • Proven track record of successful management of product safety matters (global submission, labeling negotiation, regulatory inspection, etc.)
  • Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information highly desirable

In this role, we're looking for a leader who will :
  • Act as an Owner
  • Be Excellence Focused
  • Act as an Influencer


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.