Safety Deliverable Manager

Purpose:

This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and
Patient Safety (PPS) organization’s Global PV Strategy Management Office. The PPS organization works
collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand
and communicate the safety profile of our drugs to protect patients worldwide.
The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the
product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative
safety-driven strategies, which will maximize product benefit-risk for patients.
As a Safety Deliverable Manager within the Office of the PST, you are in a highly visible role that provides
various opportunities to influence and drive operational excellence by providing strategic management and
quality authoring of PST Safety Deliverables.

Responsibilities:
 Demonstrates advanced project management skills to lead strategy discussions and drive
completion of mature and non-mature product safety deliverables (e.g., aggregate safety reports,
assessment reports, medical safety assessments) with increasing autonomy and in accordance with
regulatory requirements and procedures, and in collaboration with cross-functional stakeholders.
 With increasing autonomy, applies sound medical judgment to effectively evaluate, interpret, and
synthesize scientific data and translate into clear and concise safety summaries for inclusion in
mature product safety deliverables.
 With oversight, applies solid knowledge and understanding of applicable regulations (e.g., ICH,
FDA, EMA, GCP) to lead authoring and review of assigned safety deliverables in accordance with
standard operation procedures.
 Identifies and manages emerging risks and issues that arise during preparation of safety
deliverables (e.g., risk to timeline, new regulatory request impacting the deliverable) and ensures
they are mitigated and escalated as appropriate.
 Drives document quality through execution of quality control measures (i.e., safety deliverable QC,
oversight of stakeholder review, and archival of supporting documents).
 Leverages applicable systems, regulations and processes to enable successful, on-time completion
of safety deliverables.
 Mentors, and supports training of, less experienced Safety Deliverable Excellence team members
on targeted SDE processes as directed.
 Works and collaborates effectively to build, leverage and maintain relationships across functions
and organizations to create high quality safety deliverables within specified timeframes.
 Proactively seeks out opportunities to improve overall safety deliverable operational and quality
excellence; may lead related inter-department and/or cross-functional process-improvement projects.
 Ensures challenges related to safety deliverable quality, including internal and external feedback,
are captured, assessed, and reviewed for improvement.
 May participate in audit and inspection preparation and execution activities.

Qualifications:

Required education:
 Bachelor’s degree in a Health Sciences discipline (e.g., Pharmacy, Nursing, or other
healthcare profession)

Preferred education:
 Master’s or advanced degree is desirable

Required Experience:
 At least 3 years of pharmaceutical industry experience. Experience within Pharmacovigilance,
medical writing, and/or post-marketing aggregate report authoring is desirable but not required.
 Excellent written and spoken English
 Demonstrated working knowledge of global regulatory framework for aggregate safety reports
 Solid understanding of medical concepts and familiarity with drug development and postmarketing safety activities
 Understanding of tools, standards and approaches used to evaluate drug safety
 Exposure to medical and scientific writing, with ability to analyze, interpret and synthesize medicalscientific data and translate it into a succinct and concise written summary
 Familiarity with working in a multidisciplinary, matrix team situation while also independently
carrying out responsibilities
 Extremely detail oriented with excellent project management skills and proficiency with Microsoft
Office applications (e.g., Word, Excel, PowerPoint)

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

Salary : $82,800 - $105,000