Manager, Drug Safety & Pharmacovigilance
Manager, Drug Safety & Pharmacovigilance
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Salary Not Disclosed
1 Vacancy
Job Description
Position Summary
The Pharmacovigilance (PV) Systems Manager will serve as the primary owner and subject matter expert for Acadias Argus Safety Database ensuring the system is secure compliant and optimized to support global safety operations. This critical role combines technical expertise vendor management and regulatory knowledge to maintain the integrity of safety data enable efficient reporting and support pharmacovigilance and regulatory submission activities.
The PV Systems Manager will lead all aspects of system oversight from daily operations and helpdesk support to vendor governance upgrades validation and reporting. This individual will collaborate cross-functionally with IT Quality Clinical and Regulatory teams to ensure seamless safety system performance data integrity and audit readiness. The role requires strong project management skills deep understanding of PV workflows and regulations and the ability to translate business needs into system solutions.
As the Argus Safety Database owner this position is central to ensuring that Acadia remains compliant with evolving global pharmacovigilance regulations while enabling proactive safety surveillance that ultimately protects patients.
Primary Responsibilities
Execution of weekly monthly and ad hoc reports from the PV database.
Serve as the primary system owner for the Argus Safety Database overseeing its configuration maintenance and performance.
Manage the safety database hosting vendor including service-level agreements (SLAs) issue resolution change control and compliance.
Oversee the PV systems helpdesk and ensure timely resolution of user issues and support requests.
Coordinate system upgrades validation activities and patch releases in collaboration with IT Quality Assurance (QA) and the hosting vendor.
Develop and maintain system documentation including user guides Standard Operating Procedures (SOP) and configuration specifications.
Design generate and validate routine and ad hoc reports to support regulatory reporting signal detection and safety surveillance activities.
Collaborate cross-functionally across departments and external stakeholders to ensure compliance with global regulatory requirements (e.g. FDA EMA MHRA PMDA).
Monitor and enforce user access controls data security protocols and audit readiness.
Provide system training and onboarding support for Argus users.
Represent PV Systems in audits inspections and cross-functional initiatives.
Perform other duties as assigned.
Education/Experience/Skills
Bachelors degree in Life Sciences Information Technology or a related field. Targeting 5 years of progressively responsible experience in pharmacovigilance with at least 2 years managing Argus Safety or similar safety databases. An equivalent combination of relevant education and experience may be considered.
Key Skills:
Experience managing external vendors and service providers.
Strong knowledge of global pharmacovigilance regulatory requirements and ICH guidelines.
Proficiency in safety database reporting tools (e.g. Argus Insight SQL OBIEE Cognos).
Understanding of system validation (CSV) change management and audit readiness.
Excellent analytical reasoning and problem-solving capabilities with the ability to solve problems.
Excellent interpersonal and collaborative skills with a professional demeanor with the ability to interact with colleagues cross-functional partners and vendors.
Strong organizational and time management skills with the ability to multitask & prioritize own efforts.
Must be able to travel domestically on occasion.
Physical Requirements
This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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Required Experience:
Manager
Employment Type
Full Time
