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Morphic Therapeutic, Inc.
, MD, United States
Description About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and disc
Job Source: Morphic Therapeutic, Inc.Page Mechanical Group, Inc.
, MD, United States
JOB SUMMARY: Aveo offers an exciting opportunity for an experienced Pharmacovigilance Director to join a rapidly growing biotech company and play an integral role in building a Pharmacovigilance infrastructure. This person will oversee clinical safety across various compounds in clinical development. This person needs to be highly motivated and is
Job Source: Page Mechanical Group, Inc.PharmaGroww
, MD, United States
About the job Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injecta
Job Source: PharmaGrowwIntellia Therapeutics, Inc.
, MD, United States
Senior Medical Director, Drug Safety and Pharmacovigilance Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you
Job Source: Intellia Therapeutics, Inc.BioCT Innovation Commons
, MD, United States
Description Passionate about patient health and safety? We have an exciting opportunity for you! Our dedicated TA CRM Team is looking for an experienced Executive Director of Patient Safety Physician with expertise in cardiovascular, renal, metabolic, and/or respiratory diseases. You'll work on a variety of products, both in clinical developm
Job Source: BioCT Innovation CommonsSanofi
, MD, United States
Hiring Manager: Head Scientific Communications/ Team lead % of travel expected: Travel required as per business need Job type: Permanent and Full time About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General M
Job Source: SanofiADC Therapeutics SA
, MD, United States
Description Global Safety Physician New Providence, NJ/Hybrid/Remote Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission. Why ADC Therapeutics ADC Therapeutics (NYSE): is a commercial, global leader and pi
Job Source: ADC Therapeutics SAAllergan
, MD, United States
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and
Job Source: Allergan, MD, United States
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics Solid Dosage Formulations.
Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sitedat Roorkee, Uttarakhand and Salisbury, Maryland, USAengaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets.
Case processing / data entry and related activities in the Argus safety database as per DE conventions within specified timelines.
Participate in downloading, triaging, uploading and book-in of regulatory and EMA MLM ICSR reports.
Participate in triaging and book-in of literature reports.
Triage, Case book-in, data entry & archiving.
Ensure use of PV-MedDRA for coding adverse reactions
Documentation
Ensure that pharmacovigilance SOPs, procedures, processes, and guidelines are adhered to communicate with external and internal customers in a timely manner, as per the requirement.
Statutory Compliances
Maintain an awareness of current legislation associated withthe Worldwide Regulatory Pharmacovigilance requirements.
Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations.
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Executive-Pharmacovigilance jobs in , MD, United States
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