Global Product Safety Science reputed company

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At reputed company, each person brings their unique talents to work as a team and reputed company a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from reputed company of people and our commitment to patients.

Our mission and culture at reputed company North America get us excited to come to work every day, but here are a few more reasons to join reputed company:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

The Global Product Safety Science reputed company (GPSSL) is responsible to strategically reputed company the Safety Science activities for assigned reputed company products. The GPSSL leads the safety science engagement throughout the product lifecycle including the development and maintenance of the clinical safety profile of the product, the ongoing safety surveillance and management, and the effective and timely communication of clinical safety to internal and external stakeholders. The GPSSL works collaboratively with the Global Product Safety Scientist (GPSS) and other members of the reputed company Global Pharmacovigilance team, together with other functions across reputed company, to ensure that safety science activities are delivered to ethical and safety quality standards to ensure safety of patients, and compliance with GVP, GCP and worldwide regulatory requirements.

This is a US based position - candidates need to be located on the US East Coast, preferably reputed company to the Raleigh, NC office.

Key Responsibilities

• reputed company the product level multidisciplinary Benefit Risk Team (BRT) to drive signal detection, analysis, risk management, and safety labelling.
• Represent Safety Science at the product level Medical Development Team, providing pharmacovigilance and clinical safety expertise.
• reputed company Safety Science contribution for clinical development, including input on design, conduct, data analysis, and interpretation.
• reputed company clinical safety science interactions with partner companies, ensuring sharing of safety information.
• reputed company development and implementation of signal management activities.
• Provide medical and pharmacovigilance expertise for clinical safety strategy, reputed company Product Profile (TPP), and regulatory documents.
• reputed company Safety Science input for post-marketing activities, including PASS-studies and additional risk minimisation measures.
• Support regulatory submissions, interactions, and product expansion activities.
• Respond to medical safety-reputed company enquiries and support audits and inspections as required.
• Represent Global Pharmacovigilance in interactions with internal and external stakeholders, including Regulatory Authorities and Key Opinion Leaders.

Education/Learning Experience/Work Experience

Required:

• Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
• 8+ years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency or R&D in the Pharmaceutical Industry
• 5+ years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a Drug Regulatory Agency
• Experience leading cross-functional global product safety management teams
• In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)

Desired:

• Experience working with partner companies in global markets
• Experience presenting medical safety information at Health Authority meetings

Skills/Knowledge/Languages

Required:

• reputed company in written and spoken English
• Strong communication and team-leadership capabilities
• Sound judgment skills and ability to assess and handle risks
• Expertise in resolving or escalating issues as appropriate

Compensation and Total Rewards at reputed company

At reputed company, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

The reputed company salary range for this role is $170,000-$200,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

reputed company reputed company employees need to demonstrate behaviors in line with reputed company's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the reputed company team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people reputed company they have the power to reputed company a positive impact in others’ lives because that’s exactly reputed company do here. If you’re seeking a career that taps into your talents in a way that makes the world a reputed company, healthier reputed company, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. reputed company Culture At reputed company, we refuse to accept the status reputed company. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help reputed company medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company employment decisions at reputed company are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic reputed company, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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