9 Literature Surveillance Jobs

As a Safety Aggregate Report Specialist, you will be responsible for applying your knowledge and expertise in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your essential functions will include: - Serving as the principal owner of the SARA deliverables, ensuring their completion in compliance with all applicable service level agreements (SLA). - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings. - Authoring responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products and assisting...

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead, utilizing your 7+ years of experience in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include: - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory agency inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products, identifying ICSRs, evaluating events, and contributing to literature deliverables for aggregate reports and signal management activities. - Serving as a Signal Management Lead on large post-marke...

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you ...

As a Scientific Writing Lead at our technology-led healthcare solutions provider, your role will involve serving as a subject matter expert for medical communications. You will be responsible for various tasks including conducting medical reviews, delivering high-quality literature searches, leading and upskilling a team of scientific writers, participating in client meetings, and collaborating cross-functionally with different teams. Your goal will be to ensure exceptional document delivery and maintain client satisfaction metrics. Key Responsibilities: - Serve as a subject matter expert for medical communications, including various types of medical content. - Demonstrate expertise in assig...

As a Safety Specialist, your primary responsibility will be to receive, triage, and process individual case safety reports (ICSRs) in a timely manner. You will accurately enter event data into PV databases and code medical terms using MedDRA / WHO-DD codes. It will be your duty to assess the seriousness, causality, and expectedness of cases, as well as conduct literature surveillance to identify potential safety signals. Additionally, you will play a key role in assisting with the preparation of case narratives, reports, and documentation. You will support the creation of aggregate safety reports such as PSURs and RMPs. Ensuring strict adherence to SOPs and regulatory standards will be cruci...

You will be responsible for performing various activities on behalf of the Marketing Authorization Holder. Your main responsibilities will include maintaining oversight of the Pharmacovigilance (PV) system in all relevant aspects, such as SOPs & Training, contractual arrangements, databases, compliance data, audit/inspection plans, PV systems of local affiliates, and ensuring that all PV processes are conducted in accordance with pertinent regulations. Additionally, you will oversee the preparation and maintenance of the PV System Master File, maintain an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products, manage the signal management ...

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead for Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include leading, authoring, and finalizing various aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory inquiries. You will also be involved in literature surveillance, signal management activities, and benefit risk management documents. In this role, you will play a key role in setting up, implementing, and leading safety management teams for post-marketing and clinical trial projects. You will be responsible for overseeing signal detection...

The Global Safety Therapeutic Areas at Amgen serve as the safety experts for all Amgen products globally. They are responsible for defining the safety strategy and major safety deliverables for each Amgen product. As a leader in the therapeutic area safety teams, you will oversee staff management and resource allocations in Global Patient Safety. Your role will involve supporting GPS in establishing a highly effective global safety organization that complies with worldwide regulations. As a Global PV Sr. Scientist, you will collaborate with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Additionally, you will provide scientific and ...

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and c...