Pv Physician Ii

**Company Description** We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...

Job DescriptionThe Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS, PBRERs, PADERS).• To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE)...

**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance,...

Job DescriptionResponsibilities include:To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness / expectedness and Company causality, as well as writing of Company comment,...

Job DescriptionFor the Client:To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.To act as a...

Job DescriptionThe Associate Medical Director needs to work with the Head of Medical Operations/Medical Director on the following:• Assignment of the PV physicians to client projects• Ensuring adequate and appropriately qualified physician resources across client projects• Ensuring quality, compliance and efficiency for physician activities within a...

s (PPDs). - Screens local scientific literature for identification of PV relevant information. - Give support for local Pharmacovigilance Agreements (PVAs) with LPSL’s guidance in cooperation with Global Partner Management - Support of cross-functional colleagues in case of PV process related questions to IIS /NIS / local studies. - All relevant documents...

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

**Division**: - Quality**Department**: - Quality**Employment Type**: - Permanent**Job Purpose**: Provide healthcare professionals and patients with complete and impartial information and minimize potential risks associated with Cipla products to comply with the regulatory requirements and guarantee safety of our medical products **Accountabilities**: I....

**About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

Division Research and Development / Global Drug Development / Worldwide Patient Safety/Medical Safety Assessment (MSA) Functional Area Description The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including...

**Position Type**: Full time **Type Of Hire**: Experienced (relevant combo of work and education) **Education Desired**: Bachelor of Information Technology **Travel Percentage**: 0% **3+ Yrs - Wintel System Admin (Azure, Citrix, M365, Intune, Windows Server, AD admin., VMWare admin., Exchange) for Bangalore location.** **About this team**: The Corporate...

Sample responsibilities for this position include: Daily activities involve Have in-depth product knowledge, serve as product point of contact, and support Safety Management Team deliverables Partner with team members, stakeholders including Medical Safety Officer (MSOs), and a vendor Strategically plan and ensure timely, quality reports/safety analyses...

Position Responsibilities General Product Support Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile. Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health...

Reporting into the Senior Manager RMA / Head RMA this position participates in the initiation, oversight and follow-up of assigned clinical studies and medical projects initiated within the EPD Medical Organization, ensuring that activities are carried out in accordance with relevant processes and procedures. The RMA interfaces with other key members of the...

**Job No.** JMS 02 **Department** Medical Staff **Location** Mumbai **Work Experience** 0 - 5 Years **Qualification** MBBS, MD/DNB Pathology Or Transfusion Medicine **Description** - Administration, oversight and coordination - a) overall supervision - b) inventory management - c) fulfilling regulatory requirements - d) records and reporting - e)...

**Division**: - IPD**Department**: - IPD**Employment Type**: - Permanent**Job Purpose**: Provide support to RA by preparing regulatory medical writing documents for dossier filing and renewal **Accountabilities**: I. Preparation of medical writing documents to support of product registration and life cycle globally except for India II. Provide insights...

**About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

**Division**: **Department**: **Employment Type**: **Job Purpose**: Primary point of contact for compliances in the organisation Administer compliance manager tool for monitoring compliances applicable to the organisation globally Assist the Compliance Lead in global compliance management Assist organisational Functions in compliance awareness with suitable...

**Company Description** RESPONSIBILITIES: **2. **Serve as a point of contact within the Medical Affairs team for external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in assigned therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use. **3....