Executive Medical Director / Vice President, Drug Safety and Pharmacovigilance Physician
Our client is a leading High Growth Oncology focused Biotech looking to expand their PV team bringing on an ED / VP Drug Safety and Pharmacovigilance Physician to serves as a critical medical and data analytical expert for the assigned investigational.
What You’ll Do
- Act as the SME responsible for the development of proactive risk management strategies for a portfolio of core strategic (high profile and / or high volume and / or high complexity) investigational products within Oncology.
- Create and implement risk management strategies for assigned
- Analyse and produce safety evidence and perform safety & efficacy analyses to support the overall plans for the team.
- Provide expert medical input to regulatory documents
- Interpret clinical trial safety data for clinical trial reports and submission documents
- Ensure patient safety while adhering to the highest quality and ethical standards
- Represent Pharmacovigilance data to internal and external multidisciplinary committees & bodies
Qualifications
- MD Required.
- Exposure to Therapeutic Areas is preferred : Oncology
- Extensive experience in Pharmacovigiliance at a pharmaceutical company on a working on Global Clinical Trials and clinical development and post-marketing safety.
- In-depth understanding of research methods and procedures; strong background in epidemiological theory, methods, or health informatics is a plus.
- Excellent verbal and written communication skills.
- Strong organizational, project management, and leadership skills.
- Attention to detail and ability to think critically required.
Senior Director, Global Drug Safety & Pharmacovigilance Physician
Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director, Global Drug Safety & Pharmacovigilance Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for the assigned Genmab products (investigational) throughout their li...
Director for the Office of Global Safety and Security
They lead directly on issues of governance, standards, policies, and assurance for GS&S and supervise the work of the associate director for intelligence and crisis management and the assistant director for training and traveler support. Advise the Vice Provost for International Affairs and other Un...
RWJBarnabas Health and Rutgers Robert Wood Johnson Medical School are Seeking Pediatric Infectious Disease Physicians in New Jersey
Cooperman Barnabas Medical Center has long been recognized as a leader in providing the highest level of patient care-delivering nearly 5,800 babies annually, caring for more newly diagnosed cancer patients, creating breakthroughs in the field of infertility, and providing more than 100 medical and ...
Executive Director, Global Head of Cybersecurity and IT Risk Management
Problem solving skills and ability to work under pressure; Business and strategic acumen and ability to manage expanding levels of complexity; Fluent in English; Excellent verbal and written communication skills and executive presence; Broad level of interpersonal skills and flexibility; Cultural se...
Associate Director, Global Drug Safety & Pharmacovigilance Scientist
As an Associate Director of Drug Safety and Pharmacovigilance Scientist, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug related activities in close cooperation with Safety colleagues along with cross-functional team members. RN...
Director Drug Safety & Pharmacovigilance Operations
Updates key documents including Safety Management Plans, Vendor Oversight Plans, Safety Reporting Forms, narratives and AOSE templates, and other safety related documentation as needed</li><li>Ensures training of appropriate cross-functional personnel and external groups in drug safety p...
Executive Director, Global Head of Cybersecurity and IT Risk Management
The link below leads to the machine-readable files that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers. We start at the earliest stages of discovery and...
Vice President & Pricing Actuary – PR12681
Manage small team involving pricing E&S Commercial Property Liability and Inland Marine business; collaborate on profitability and business strategy; liaise with Predictive Modeling team and Reserving Actuaries. Vice President & Pricing Actuary opening New Jersey. Ideal candidate is FCAS with 10+ ye...
Medical Receptionist -Advanced Lung & Airway - Physician Practice
The ability to learn quickly and adapt to changing patient needs, a strong sense of accountability for improving the lives of our patients and their caregivers, an exceptional focus on teamwork, dedication to ongoing education, and the ability and passion to deliver the highest quality of care based...
Vice President, Media & Archiving Services
We offer comprehensive records and information management services and data management services, along with the expertise and experience to address complex storage and information management challenges such as rising storage rental costs, legal and regulatory compliance, and disaster recovery requir...