Manager, PV Information & Systems

Position Summary:

The Manager, PV Information & Systems, will provide PV operational expertise in support of complex SaBR (Safety and Benefit Risk) PV Systems. This role is responsible for supporting cross functionally in the coordination and development of SDB configurations, analytics, submissions, and compliance activities. The successful candidate will have a proactive and innovative approach with a flexible, hands-on nature and will work with a high sense of urgency. Effective and open communication skills are key to ensure integration into Apellis and the SaBR team.

Key Responsibilities Include:

• Execute and provide ongoing support for Pharmacovigilance (PV) analytics, ad-hoc reporting, oversight dashboards, data analysis, and reporting activities.
• Support data management (e.g., line listings, reports, etc.) for ad-hoc, signal detection, audit, and authority inspection outputs/listings as needed.
• Assist in the deployment and integration of new safety technologies (e.g., Global Safety Database, change management systems, etc.) and PV technology enhancements.
• Collaborate with cross-functional teams to translate user requirements (e.g., Out-of-the-Box features vs. Configured vs. Customized features) into clear, actionable requirements.
• Contribute to the resolution of complex issues in a dynamic, fast-paced, and collaborative team environment.
• Provide support to business process owners on PV business initiatives, including change control, data requests, and User Acceptance Testing (UAT), to foster continuous business process improvements.
• Aid in the development, review, and validation of lifecycle documentation to ensure compliance and quality.
• Ensure ongoing training compliance and maintain necessary certifications.
• Perform additional duties as required to support team goals and organizational priorities.

Education, Registration & Certification:

• Degree in a business, scientific, or technical discipline (e.g., Health Science, Computer Science, etc.), or equivalent.

Experience:

• Minimum of 4 years of biotech/pharmaceutical industry experience, including at least 2 years in a drug safety/pharmacovigilance role (ie. Ad-hoc reporting, safety database configuration and management, vendor oversight, case management).

Skills, Knowledge & Abilities:

• Knowledge of PV Systems, database administration, computerized system validation and data retrieval.
• Functional understanding of drug safety and pharmacovigilance and of all aspects of drug development.
• Functional understanding of GxP and ICH guidelines.
• Functional understanding of global safety database implementations/upgrades or business process improvement.
• Experience with writing and executing PQ scripts for testing and validation.
• Strong collaboration skills.
• Excellent oral and written communication skills.
• Proficient working knowledge of standard office software tools (e.g. MS Office including Excel, Word PowerPoint, SharePoint, Visio/Lucid Chart, Smartsheet/MS Project, etc.).
• Ability to work in a support role with flexibility to thrive in a fast-paced environment.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Expected travel will be required, up to 10% 

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targetin