Pharmacovigilance Associate

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 Affairs...

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 and...

Job OverviewLead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Be responsible for end-to-end report management, including planning, authoring, and managing review, approval, and submission steps, per project scope and requirements. Apply safety domain knowledge and process expertise to...

DescriptionCRA II/ Sr CRA I (Mumbai Location, Client based) (Oncology)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the...

**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...

As a Pharmacovigilance Associate you are part of the Pharmacovigilance Department (sometimes called the Drug Safety Department). Your role is one of reporting adverse effects (AEs) and side effects, in accordance with the current Dutch and European legislation for pharmacovigilance. You may also train colleagues in departments such as marketing and sales,...

**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...

**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...

Excent Research is currently seeking to expand its Research and Development team for its Pharma Division. As part of this effort, we are actively recruiting for the positions of Pharmacovigilance Associates and Clinical Researchers. Eligibility: BSc, MSc, B Pharmacy, M Pharmacy, PharmD, Any UG / PG in Life Sciences **Job Types**: Full-time,...

Basic understanding of pharmacovigilance processes and regulatory requirements. - Strong attention to detail and accuracy in data entry and report preparation. - Ability to work in a team and follow instructions from senior professionals. - Proficiency in MS Office (Word, Excel, PowerPoint). - Good written and verbal communication skills. - Eagerness to...

Processing adverse events reports from post marketing sources into Teva's global safety database: - The different sources / types of reports includes: Reports from the scientific literature, Teva partners (other pharmaceutical companies), Health Authorities, Non-interventional studies and other programs - The processing includes Adverse Events coding (in...

**Responsibilities**: - Monitor and report adverse drug reactions (ADRs). - Prepare safety reports and ensure regulatory compliance. - Collaborate with healthcare professionals on drug safety. **Qualifications**: - Degree in Pharmacy, Life Sciences, or related field. - Knowledge of pharmacovigilance and medical terminology. - Strong analytical and...

Provide medical and clinical guidance to managers before, throughout, and following clinical trials. - Maintain consistency of safety assessments. - Perform a variety of safety assessments. - Serve in cross-functional teams as a medical and scientific representative. - Ensure regulatory compliance and safety throughout trial. - Submit periodic reports to the...

Collect, review, and process adverse event reports from clinical trials, post-marketing sources, and literature. - Ensure timely and accurate entry of safety data into safety databases (e.g., Argus, ARISg). - Prepare and submit Individual Case Safety Reports (ICSRs) to regulatory authorities within stipulated timelines. - Conduct follow-ups with healthcare...