Senior Manager (Level 1), Pharmacovigilance Epidemiology & Risk Management

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

• Responsible for the planning, execution and documentation of CSV according to internal procedures and external requirements (e.g. GxP, GAMP 5, 21 CFR Part 11)
• Working with all technology teams by reviewing work carried out when necessary to identify compliance issues and improvements by providing advice or training.
• Evaluate our validation procedures to ensure they are efficient across the product base identifying where improvements can be made.
• Ensure our validation process and approaches are fit for ensuring both quality and speed to value to the business while maintaining compliance.
• Working with technology teams ensure the upkeep of documentation and evidence as required by standard operating procedures are being carried out.
• Representing the department processes and created/adopted solutions in external client audits.
• Risk assessing solutions being adopted for use internally and advising on best approach to ensure compliant system adoption.
• Approving Validation Plans, accountable for ensuring that a robust risk assessment and mitigation strategy has been implemented.
• At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment.
• Good knowledge of cGxP regulations and software lifecycle approaches (e.g., GxP, GAMP 5, 21 CFR Part 11)
• Good communication skills
  

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.Full time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned