Senior Medical Director, PST Lead-Neuroscience
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 can be remote
The Senior Medical Director, PST Lead 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 Allergan 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 Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
- Medical risk Management
- Leads 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.
- Evaluates patient risk impact arising from deviations from product quality specification.
- Provides comprehensive recommendations on Risk Management strategies to Global Safety Board (GSB).
- Collaborates on authoring safety specification section of RMP and REMS documents and updates. Reviews and approves RMPs and REMS. In collaboration with relevant stakeholders evaluates effectiveness of risk minimization actions. Prepares safety statements for safety relevant communication purposes such as Dear HCP letters. Supports product acquisitions, due diligence, legal issues and recalls, as appropriate.
- Aggregate safety review and signal detection
- Leads safety reviews and signal detection of assigned pre- marketed products.
- Reviews and approves signal detection activities for postmaketed products.
- Makes data-driven decisions and writes safety review documents and reports.
- Determines resolution of signals.
- Evaluates and make recommendations on actions arising from signals in collaboration with the SMT.
- Escalates appropriate signals to GSB/CMO.
- Development and maintenence of core safety information
Participates 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.
Participates 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 initiates appropriate action.
Updates pre-marketing and post-marketing safety information and provides the justification documentation for any changes to IBs and CCSIs
Clinical development safety
- 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).
- Evaluates all safety data generated in clinical trials.
- Participates in global teams to provide medical safety leadership and development of risk management strategy.
- Liaises with assigned Data Safety Monitoring Boards.
- Responds to safety questions from investigator sites and IRBs regarding safety issues and queries.
- Provides medical safety interpretation of safety findings for all clinical study reports, including final review of safety relevant adverse event coding for assigned projects and discusses, proposes, and communicates any revision(s) or additions.
- Ensures regulatory reports (e.g., clinical study reports, NDA, BLA) accurately reflect proper safety interpretation of the clinical study findings.
- Leads, authors and owns 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.
- Leads safety response to health authority assessor questions after filing and response to Health Authority inquiries on clinical studies, when necessary.
- Aggregate safety reports
- Authors relevant safety sections of aggregate reports (PSUR, PBRER and DSUR) and conclusions of product safety profile for these aggregate reports.
- Reviews and approves the aggregate reports.
- Contribute safety sections and risk/benefit assessment, if required, to Annual Safety Reports / IND annual reports.
- Reviews to ensure regulatory reports accurately reflect proper interpretation of findings. Assists in the preparation of safety sections and review of regulatory documents.
- Leadership, people management and personal development
Leads recruitment and manages resources in therapeutic area. Identifies and creates development opportunities for staff.
Prioritizes work of direct reports.
Trains direct reports and new physicians.
Ensures compliance with relevant policies and procedures.
Assists with review of group performance metrics. Assists with resolution of complex, cross-functional issues.
Contributes to the mentoring and on-boarding of new colleagues.
Uses the company performance management process to manage individual development.
Develops and maintains 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.
Maintains knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development.
Develops inspection readiness for medical assessment activities and supports regulatory authority inspections when required.
Represents Allergan 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.
Liaises with internal and external experts / Key Opinion Leaders to obtain specialized medical expertise appropriate.
Leads or contributes as an individual to projects / process improvements that support GPSE’s strategic objectives.
This is an individual contributor position
- M.D. or equivalent
- Specialized in Neurosciences with clinical experiences highly desirable
- 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
Significant Work Activities
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.