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Jubilant Pharma, LLC
, 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-steri
Job Source: Jubilant Pharma, LLCIntellia 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.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.Sanofi
, 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: SanofiPharmaGroww
, MD, United States
About the job The Pharmacovigilance Specialist collaborates with the Lit Search/Medical Writing team and clients to analyze and report on safety findings, within the context of patient safety and efficacy against our clients’ drugs and products. The Pharmacovigilance Specialist ensures effective and clear documentation and communication of safety
Job Source: PharmaGrowwPharmaGroww
, 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: PharmaGrowwADC 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 SAAmerican Academy of Neurology
, MD, United States
The Role The Vice President (VP), Neuromuscular Clinical Development, reporting to the Head Clinical Development with a dotted line to the Integrated Product Team (IPT) Leader for AskBio’s Neuromuscular programs, will be responsible for developing and implementing the IPT’s clinical development strategy for clinical programs spanning all stages of
Job Source: American Academy of Neurology, 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 expected to provide innovative, critical, and strategic input and leadership.
PRINCIPAL DUTIES: The incumbent will have the following key responsibilities:
Provide safety and pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs.
Be accountable for identification, assessment and communication of potential safety signals; generate and analyze trend analysis reports.
Collaborate with Regulatory Affairs to ensure appropriate reporting of PV and drug safety information to regulatory agencies and prescriber community.
Lead development of SOPs for PV and drug safety monitoring.
Provide oversight and key input for review of new or on-going safety documents that ensure compliance with domestic and international regulatory requirement, such as protocols, safety summaries and regulatory reports.
Oversee preparation and quality control activities for key safety documents (familiarity with existing safety systems such as ARISg is a plus).
Give key input in review and finalization of clinical protocols and other study-related documents
Collaborate with a team of professionals who provide medical monitoring support for ongoing clinical trails on a global basis. Opportunity exists for direct medical monitoring of early clinical trials.
Develop relationship with and capture drug safety info from key groups, including partner companies, physicians, nurses and patient advocacy groups.
Provide input to potential in-licensing opportunities and pharmacovigilance agreements with commercial partners.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
Medical Degree (MD) or international equivalent
At least 5 years experience in drug safety/pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
Excellent verbal, written and presentation skills
Ability to build relationships and influence across disciplines and all levels
PREFERRED QUALIFICATIONS/EXPERIENCE
Accredited fellowship or clinical experience in Oncology
Clinical experience, including training, in Internal Medicine or a related specialty
Familiarity with EU safety reporting and Eudravigilance is desirable
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Head of Pharmacovigilance jobs in , MD, United States
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