Senior Product Manager, Safety Operations (Remote)
Senior Product Manager, Safety Operations (Remote)
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
This position reports into the Safety Operations Product Leadership team which is part of the International Strategy & Safety Operations (ISSO) function in Patient Safety. The Patient Safety 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. ISSO oversees the intake processing and reporting of patient safety information.
Responsibilities:
With oversight of the Oncology Portfolio Lead the Sr. Product Manager oversees the accuracy completeness and timeliness of all Safety Operations scientific activities and deliverables for Oncology and/or focused disease state. These activities/deliverables include support and input into the lifecycle of the asset (from preclinical clinical trial and post marketing deliverables) submissions and product launches studies scientific collaborations etc.
With oversight of the Portfolio Lead responsibilities include:
- The Sr. Product Manager is the point of contact for Product Safety Teams QPPV and PPS Leadership contextualization of Adverse Event data (from an ICSR perspective) for focused therapeutic product and/or disease state for global regulatory responses audits/inspections proactive safety communications etc.
- Collaborates with Data Management or Business Technology to extract required data and reports.
- Supports and provides guidance to the Safety Operations Product Managers to prepare communication materials that contextualize the data in a meaningful way in order to facilitate highquality safety responses and narratives.
- Partners with the Product Safety Team (PST) to provide input on study protocols Urgent Safety Measures/Unanticipated Problems (USM/UP) animal and toxicology reports global regulatory agency requests and inspection support.
- With oversight from Portfolio Lead support the maintenance and identification of RSI responsibilities for assigned product. May collaborate with crossfunctional RSI stakeholders for periodic maintenance.
- Leads effective crossfunctional collaboration for focused therapeutic product and/or disease state with an emphasis on building business relationships with relevant AbbVie stakeholders including Patient Safety Commercial GMA RDQA and Affiliates to establish and maintain harmonized ICSR processes.
- Support crossfunctional training requirements to support the Safety Operations Product Leadership (SOPROL) organization within ISSO.
- Supports the ISSO stakeholders on acquisitions outsourcing and collaboration initiatives within Oncology. With oversight from Portfolio Lead provides product oversight of outsourced studies by reviewing and contributing to the Safety Management Plans.
- Participates in audits and inspections. Prepares materials related to Adverse Event data and decisions as it relates to product strategies. Engages in frontroom interviews. Supports PST Leads International PV Network and other stakeholder groups in preparation for audits and inspections.
- Proactively communicates productlevel insights on Adverse Event data (from an ICSR perspective) within ISSO.
- Functions as the Safety Operations Sr. Product Manager for focused therapeutic product and/or disease state from discovery through approval for the life of the product. Supports all types of studies including phase I through phase IV Post marketing Observational Studies (PMOS) Investigator Initiated Studies (IIS) and collaborations studies.
- Determines when PV blind breaks should be processed for end of study blind breaks. Functions as a blind break decision maker for blind breaks due to safety concerns and health authority requests. Assists the management of the Blind Break Process and provides input into proposed improvements and updates. Evaluates for efficiencies gained.
- Liaises with Global Medical Affairs (GMA) on GMA sponsored studies by providing input on safety data collection protocol and contract review to ensure safety language is correct and in compliance with the global regulations.
- Leads process improvement initiatives with effective change management and rapid solutioning of unanticipated issues related to SOPROL and/or productrelated ICSR safety issues.
- Leads identification prioritization and timely resolution of potentially impactful issues including clear communication and followup across stakeholders through resolution prevention and trending related to SOPROL and/or productrelated ICSR safety issues.
- Provides input to Safety Operations ICSR forecasting process by providing relevant productspecific insights on studies (planned active completed) regulatory commitments and filings anticipated approvals/launches Patient Support Program strategies etc.
This role can be remote in the US.
Qualifications :
Minimum: Bachelors degree with related health sciences background; Licensed healthcare professional. RN BSN BS BS Pharm PharmD or advanced degree preferred.
- 2 years of previous experience as a Product Manager or equivalent preferred.
- At least 5 years experience working in the healthcare industry and a strong understanding of the drug development process.
- Minimum of 3 years of pharmacovigilance experience required.
- Strong understanding of the current global regulatory requirements that impact PV.
- Proficient in case processing processes procedures conventions.
- High emotional Intelligence and strong relationship management and communication skills.
- Demonstrated ability to collaborate and influence crossfunctionally and globally. Crossfunctional initiative experience is preferred.
- Proficient in the regulations in relation to the science for the benefit of drug safety.
- Strong leadership presence and communication skills. Strong influencing skills.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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:
Yes
Employment Type :
Fulltime
Employment Type
Remote
