Safety Deliverable Manager (Hybrid)
Safety Deliverable Manager (Hybrid)
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1 Vacancy
Job Description
This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and
Patient Safety (PPS) organizations 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
This role will be on a hybrid schedule with 3 days a week onsite in Lake County IL.
Qualifications :
Required education:
- Bachelors degree in a Health Sciences discipline (e.g. Pharmacy Nursing or other healthcare profession)
Preferred education
- Masters 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 post- marketing 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 medical- scientific 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)
- Effectively manage stressful situations multiple projects simultaneously and tight project milestone deadlines
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
