Job Details

• Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE), Medical Device Incident (MDI) information from the source document

• Accountable for Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage, Duplicate Search, Data Entry, MedDRA codding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc.

• Accountable to perform Literature Review as per the applicable organization’s SOP and WI

• Accountable preparation and/or review of aggregate reports as per applicable SOP and WI including but not limited to Annual Summary Reports (ASR), Issue Related Summary Report (IRSR), Periodic Safety Update Reports (PSURs), Periodic Benefit- Risk Evaluation Report (PBRERs), Periodic Adverse Drug Experience Report (PADER), Developmental Safety Update Report (DSUR), etc.

• Accountable for performing Signal Detection as per applicable SOP and WI Accountable for preparation and/or update of Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategies (REMS) and associated documents

• Accountable to act as a contact point for the client Work directly with internal and external stakeholders to request additional information or clarification as necessary;

• Assist in audit preparation File and store all documents as per applicable SOP and WI.

• Other tasks assigned by the Manager, as needed. May be required to be on standby / on-call as part of this role.

Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required. 2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required. Certification in regulatory affairs, quality management, compliance, auditing preferred.

Schedule

Full time

Accessibility Policy

Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Affiliated Companies

Affiliated Companies: Innomar Strategies

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