4.0 - 12.0 years

0 Lacs

karnataka

On-site

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...

Posted 2 weeks ago

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Pharmacovigilance Analyst Clariwell Global

0.0 - 4.0 years

0 Lacs

nagpur, maharashtra

On-site

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...

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Internship in Pharmacovigilance Covalent Trainings

0.0 - 3.0 years

0 Lacs

hyderabad, telangana

On-site

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 ...

Posted 1 month ago

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Safety Aggregate Reporting Manager IQVIA India

7.0 - 11.0 years

0 Lacs

maharashtra

On-site

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...

Posted 1 month ago

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Global PV Sr. Scientist Amgen

12.0 - 17.0 years

0 Lacs

hyderabad, telangana

On-site

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 ...

Posted 2 months ago

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PV Scientist Iqvia Biotech

2.0 - 3.0 years

2 - 3 Lacs

Thane, Maharashtra, India

On-site

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...

Posted 3 months ago

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