Senior Manager, Product Safety Team Program Manager
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What you'll do
- Support PSTs and safety governance bodies by managing communications and meeting logistics, facilitating team discussions and escalations, and assisting with program reviews to ensure regulatory compliance and alignment regarding product safety.
- Organize and document cross-functional PST meetings, helping deliver timely and inspection-ready safety documents that meet global requirements.
- Apply solid knowledge of drug safety and AbbVie processes to contribute to risk assessment, share insights with teams, and assist with benefit-risk, labeling, and regulatory discussions.
- Assist in audit and inspection readiness by supporting quality and safety governance teams in implementing corrective and preventive actions.
- Assist in audit and inspection readiness by providing documentation and responses and supporting quality and safety governance teams in implementing corrective and preventive actions.
- Develop and maintain safety documentation and communications to ensure clear, transparent, and compliant safety oversight.
- Build collaborative relationships within PST and with leadership, supporting a culture of effective teamwork and agile decision-making.
- Provide guidance and share best practices with peers; support and lead process improvements and contribute to team development efforts.
- Show strong communication and influencing skills when discussing safety topics with various stakeholders, including senior leaders and physicians.
- Create clear and informative presentations to support safety decisions and discussions, seeking and organizing relevant data insights from cross-functional partners.
What they're looking for
- At least 5 years’ project management experience with cross-functional teams in a global company.
- At least 5 years’ experience in healthcare, with working knowledge of the drug development process.
- Bachelor’s degree in a healthcare discipline (e.g., Life Science, Pharmacy, Nursing, healthcare profession, or biomedical disciplines) OR equivalent certification and experience required.
Nice to have
- Familiarity with Pharmacovigilance is preferred.
- Master’s or advanced degree is desirable.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
This position reports into the Clinical Sciences Product Office & Technology, within Strategic Operations under the Clinical Sciences organization. The Clinical Sciences Product Office & Technology and Global Patient Safety functions work 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 Product Safety Team Program Manager (PST PM) plays a critical role in shaping and advancing the strategic priorities of the PST by providing exceptional and strategic program management leadership. The PST is a high-profile, high-impact team that leads and owns safety decisions and strategies across the product lifecycle. The team collaborates with stakeholders throughout the product lifecycle to deliver innovative, safety-driven strategies that maximize the product's benefit-risk profile for patients.
Responsibilities:
- Support PSTs and safety governance bodies by managing communications and meeting logistics, facilitating team discussions and escalations, and assisting with program reviews to ensure regulatory compliance and alignment regarding product safety.
- Organize and document cross-functional PST meetings, helping deliver timely and inspection-ready safety documents that meet global requirements.
- Apply solid knowledge of drug safety and AbbVie processes to contribute to risk assessment, share insights with teams, and assist with benefit-risk, labeling, and regulatory discussions.
- Assist in audit and inspection readiness by supporting quality and safety governance teams in implementing corrective and preventive actions.
- Assist in audit and inspection readiness by providing documentation and responses and supporting quality and safety governance teams in implementing corrective and preventive actions.
- Develop and maintain safety documentation and communications to ensure clear, transparent, and compliant safety oversight.
- Build collaborative relationships within PST and with leadership, supporting a culture of effective teamwork and agile decision-making.
- Provide guidance and share best practices with peers; support and lead process improvements and contribute to team development efforts.
- Show strong communication and influencing skills when discussing safety topics with various stakeholders, including senior leaders and physicians.
- Create clear and informative presentations to support safety decisions and discussions, seeking and organizing relevant data insights from cross-functional partners.
Qualifications
Experience:
- At least 5 years’ project management experience with cross-functional teams in a global company.
- At least 5 years’ experience in healthcare, with working knowledge of the drug development process. Familiarity with Pharmacovigilance is preferred.
- Experience in any of: clinical operations, clinical studies, drug development, risk management, or drug safety operations.
- Experience collaborating with senior leaders or functional managers.
Education:
Bachelor’s degree in a healthcare discipline (e.g., Life Science, Pharmacy, Nursing, healthcare profession, or biomedical disciplines) OR equivalent certification and experience required. Master’s or advanced degree is desirable.
Skills/Knowledge:
- Strong verbal and written communication skills suited to diverse functional teams and leaders.
- Skilled in organizing and facilitating group discussions and project meetings.
- Able to work independently, influence team stakeholders, and present business strategies within established frameworks.
- Solid understanding of regulations and their relevance to drug safety; good working knowledge of clinical development processes and requirements.
- Demonstrated success in multidisciplinary matrix teams; ability to support change initiatives and contribute to team effectiveness.
- Adaptable and collaborative in changing environments; supports information flow and constructive conflict resolution.
- Capable of organizing and presenting project information clearly and logically.
- Or appropriate combination of education and experience.
- Posting Grade Information
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 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
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