Job
Description
As a member of the team at Cencora, you play a crucial role in contributing towards creating healthier futures. Your responsibilities will include: - Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases, and signal detection. - Writing various safety reports such as Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), Clinical Expert Statements, etc. - Publishing, distributing, archiving, and submitting safety reports. - Preparing Signal detection reports, including EVDAS screening if applicable, and Signal Assessment Reports (SARs). - Writing Risk Management Plans (RMPs) by identifying safety concerns and advising on future risk minimization activities throughout the product life cycle. - Reviewing documents for completeness and consistency, evaluating report quality, ensuring training compliance, and mentoring new staff. - Preparing responses to PRAC assessment reports and other Authority requests, collaborating with internal and external stakeholders to ensure regulatory compliance. - Formulating strategies for addressing safety issues, responses to health authority requests, and integrated benefit-risk evaluation. You may also be required to take on additional tasks in other service lines, project management activities, client contact points, and other reasonable tasks aligned with your abilities, qualifications, and training. Cencora offers a comprehensive benefits package, which may vary by country and align with local market practices. Full-time employment opportunities are available within the affiliated companies, such as PharmaLex India Private Limited. Cencora is committed to providing equal employment opportunities and a harassment-free work environment. The company prohibits discrimination in all aspects of employment and ensures compliance with equal opportunity principles in recruiting, training, compensation, benefits, promotions, and transfers. Reasonable accommodations are available for individuals with disabilities during the employment process, consistent with legal requirements. To request an accommodation during the employment process, please contact us at 888.692.2272 or email hrsc@cencora.com. Accommodation determinations will be made on a request-by-request basis. As a member of the team at Cencora, you play a crucial role in contributing towards creating healthier futures. Your responsibilities will include: - Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases, and signal detection. - Writing various safety reports such as Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), Clinical Expert Statements, etc. - Publishing, distributing, archiving, and submitting safety reports. - Preparing Signal detection reports, including EVDAS screening if applicable, and Signal Assessment Reports (SARs). - Writing Risk Management Plans (RMPs) by identifying safety concerns and advising on future risk minimization activities throughout the product life cycle. - Reviewing documents for completeness and consistency, evaluating report quality, ensuring training compliance, and mentoring new staff. - Preparing responses to PRAC assessment reports and other Authority requests, collaborating with internal and external stakeholders to ensure regulatory compliance. - Formulating strategies for addressing safety issues, responses to health authority requests, and integrated benefit-risk evaluation. You may also be required to take on additional tasks in other service lines, project management activities, client contact points, and other reasonable tasks aligned with your abilities, qualifications, and training. Cencora offers a comprehensive benefits package, which may vary by country and align with local market practices. Full-time employment opportunities are available within the affiliated companies, such as PharmaLex India Private Limited. Cencora is committed to providing equal employment opportunities and a harassment-free work environment. The company prohibits discrimination in all aspects of employment and ensures compliance with equal opportunity principles in recruiting, training, compensation, benefits, promotions, and transfers. Reasonable accommodations are available for individuals with disabilities during the employment process, consistent with legal requirements. To request an accommodation during the employment process, please contact us at 888.692.2272 or email hrsc@cencora.com. Accommodation determinations will be made on a request-by-request basis.
