Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Providing strategy based on regulatory requirements.
Completing regulatory and PV deliverables based on established plan.
Acting as Local Contact Person for Pharmacovigilance for designated country.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners and value employee experience, well-being and mental health.
Oversight of all project related quality activities
Drive project related quality improvement and providing quality advice
Client management including direct oversight for client quality related activities for project
PrimeVigilance, part of Ergomed Group, is a mid-sized pharmacovigilance service provider established in 2008. They offer services in medical information, pharmacovigilance, regulatory affairs, and quality assurance, with staff across Europe, North America, and Asia. They maintain long lasting relationships and becoming one of the global leaders in its fields.
Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures.
Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. They aim to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Their values inspire employees every day.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Lead regulatory compliance projects from initiation through completion.
Interpret new and evolving regulations and translate them into actionable project plans.
Oversee regulatory audits, assessments, and remediation activities.
SGS is the global leader in inspection, verification, testing and certification services. With over 97,000 employees in 130 countries, they provide services to almost every industry assuring quality and safety of products and services, fostering innovation and welcoming new ideas.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
You will function as a central knowledge holder in a specialized team within Pharma Regulations & Audits.
You will carry out audits and compliance checks, formulate improvement measures and supervise the implementation.
You will implement projects to improve compliance and quality processes.
Redcare Pharmacy is Europe’s leading online pharmacy driven by innovative technologies and the passion of its employees. The company strives for an inspiring and collaborative work environment where everyone feels valued and contributes to their mission: “Until every human has their health.”
This position supports the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data.
Responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts.
Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner.
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. They strive to have a remarkable impact on people’s lives across several therapeutic areas including immunology, oncology and neuroscience.