Associate Director, PV Information & Systems

Position Summary:

The successful candidate is responsible for supporting and managing pharmacovigilance and safety system/technology needs including ongoing maintenance, reporting, implementation of system projects, upgrades, and integrations. Serving as the link between the internal and external business users, IT, QA, and the PV technology vendor, the Associate Director, PV Information & Systems is responsible for supporting the evaluation of the safety database and associated reporting and signaling tools.  As a technical expert on safety systems, the Associate Director serves as an advisor to Safety and Benefit Risk (SaBR) staff on safety system issues.

Key Responsibilities Include:

• Lead and contribute to the implementation of new safety technologies (e.g., Global Safety Database, ad-hoc reporting, oversight dashboard, etc.) and PV technology vendor oversight.
• Utilize pharmacovigilance expertise to translate complex user requirements (e.g., Out of the Box features vs. Configured features vs. Customized features) into appropriate functional and system requirements.
• Own, manage, and execute activities associated with Global PV processes for PV Computerized Systems Administration, Change Control, and Change Management.
• Provides data support (e.g., line listings, reports, etc.) for ad-hoc, signal detection, audit, and authority inspection outputs/listings.
• Lead cross-functional teams (internal and external) with Stakeholders, Affiliates, and Vendors to collect and implement PV specifications and PV user requirements to ensure operational alignment of system(s) and process priorities.
• Work in fast paced collaborative team environment and drive resolution of complex, cross-functional issues.
• Responsible for supporting business process owners to support SaBR Business initiatives, including coordination, communication and change management (e.g. change control, data requests, UAT etc.) support for business process improvement.
• Writing and reviewing validation lifecycle documents.
• Assist with the development and maintenance of SaBR Systems onboarding curriculum and training.
• Additional duties and responsibilities as required.

Education, Registration & Certification:

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

Experience:

• Prefer minimum of 12 years of total biotech/pharmaceutical industry experience, including at least 8 years in a technical drug safety/pharmacovigilance role (ie. safety database configuration and management, vendor oversight, case management).
• Subject Matter Expert for PV Systems, database administration, computerized system validation and data retrieval (prefer hands-on implementation experience with safety databases like ARISg, ARGUS, etc.).
• Good understanding of drug safety and pharmacovigilance and of all aspects of drug development.
• Some knowledge of Electronic Data Capture (EDC) systems and data structures.
• Understanding of GxP and ICH guidelines.
• Experience facilitating global safety database implementations/upgrades or business process improvement initiatives including interfacing with business roles to gather requirements and ensure regulatory compliance.
• Strong leadership skills, including demonstrated ability to lead a cross-functional team, and influence at all levels of an organization.
• Excellent oral and written communication skills, including presentation and facilitation.
• 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 independently and with flexibility to handle workflow 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. 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:

• Some travel will be required, up to 15%.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, 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 targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.  

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.