Manager PV Information Systems
Manager PV Information Systems
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1 Vacancy
Job Description
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 handson 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 adhoc reporting oversight dashboards data analysis and reporting activities.
- Support data management (e.g. line listings reports etc. for adhoc 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 crossfunctional teams to translate user requirements (e.g. OutoftheBox features vs. Configured vs. Customized features) into clear actionable requirements.
- Contribute to the resolution of complex issues in a dynamic fastpaced 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. Adhoc 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 fastpaced 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! Visithttps://apellis/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop lifechanging 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 preclinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
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.
Required Experience:
Manager
Employment Type
Full Time
