Sr Manager, Global Reporting

The Senior Manager Global Vigilance Reporting provides robust leadership strategic oversight and direction for a global team responsible for vigilance reporting across the globe including US Canada and EAME regions. It holds the responsibility of ensuring the health of the Post Market Quality Assurance Complaints quality system in collaboration with peers. This role ensures rigorous compliance with current and evolving regulatory requirements while promoting proactive high-quality management practices throughout the organization. The incumbent will foster strong partnerships and drive alignment among key stakeholdersincluding Pharmacovigilance Regulatory Affairs Device Quality Assurance and Product Qualitysupporting project goals audits and surveillance activities. The role represents the company along with stakeholders in regulatory communications internal and external inspections and is accountable for maintaining up-to-date knowledge of global regulations.

Responsibilities:

Lead and inspire the Global Vigilance Reporting team to deliver excellence in all reporting activities leveraging a strategic and future-oriented mindset.

Ensure thorough identification evaluation and escalation of potentially reportable events informing relevant functions and senior leadership promptly.

Collaborate closely with Complaint Operations to proactively monitor complaint trends and ensure seamless transition and coordination between teams.

Develop and review formal documentation in compliance with GMP standards for regulatory filings and reporting (e.g. Form 3500A Med Dev).

Serve as primary liaison with Regulatory Affairs Pharmacovigilance Product and Device Quality Assurance overseeing and facilitating report submissions and continuous communication.

Manage and/or participate in cross-functional project teams focusing on process improvements new product launches and issue resolution providing expert oversight and guidance.

Direct specific areas of the reporting process ensuring efficient operations and high standards for personnel involved in each stage.

Support leadership by contributing to strategic planning and continuous improvement initiatives staying abreast of evolving country-specific regulations and external trends.

Represent the organization confidently during internal and external regulatory audits inspections and agency interactions ensuring ongoing compliance.

Qualifications :

• Bachelors degree required; preferably in nursing pharmacy medical technology engineering or related scientific field (MLT LPN RN).
• Minimum 5 years of professional experience in a cGMP-regulated industry or clinical setting (preferred).
• At least 4 years of direct people leadership experience ideally within global or cross-functional teams.
• Extensive knowledge of global regulatory requirements for pharmaceuticals medical devices and combination products.
• Familiarity with FDA Quality Systems and Medical Device Reporting regulations (21 CFR) highly preferred.
• Proven ability to prioritize and manage multiple projects within a regulatory framework demonstrating strong organizational and time-management skills.
• Exceptional written and verbal communication skills capable of engaging and influencing stakeholders at all levels.
• Proficient in leveraging computer systems for word processing and complaint management.
• Demonstrated ability to lead cross-functional teams collaborate across departments and build productive partnerships with internal and external stakeholders.

Additional Information :

At AbbVie we are committed to cultivating a workplace culture that promotes inclusion diversity and personal growth. We recognize that our collective success is based on the individual well-being of our employees which is why we have designed a benefits package that considers every aspect of their lives.

• Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance ensuring peace of mind for you and your loved ones.
• Extended Vacation: We believe in the balance between work and personal life for our administrative team. Thats why we offer additional vacation days beyond legal requirements.
• Flexible Hybrid Work Model: For eligible positions within our administrative staff we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.
• Life Insurance: Secure your familys future with our life insurance policy.  
• Employee Assistance Program (EAP): Access professional support with our comprehensive EAP offering psychological legal and financial counseling.
• On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services demonstrating our commitment to your health and well-being.
• Community and Social Engagement: Make a difference with a paid volunteer day allowing you to contribute to the community during company working hours.
• Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off.
• Employee Stock Purchase Plan: Participate in our companys success by purchasing shares at a special price exclusive to employees.
• Transportation and Meals subsidized.
• Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.

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:

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:

Work :

No

Employment Type :

Full-time