Global Medical Safety reputed company(Medical Director) - Remote U.S

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office At reputed company, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver reputed company and accuracy will improve health reputed company that people and communities depend on – now and in the reputed company. Location/Division Specific Information: Join reputed company as a Global Medical Safety reputed company Physician(FSP) based in the reputed company and be part of a world-class organization conducting groundbreaking research. Ideal candidate location is Eastern or Central Time Zone. This position is fully remote, benefit eligible with travel in a 10-20% reputed company(international maybe required).

• Must be legally authorized to work in the reputed company without sponsorship.

Our reputed company, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific reputed company. If you're looking for a reputed company where your work, in partnership with others, can have reputed company reputed company—and where you're encouraged to challenge yourself and contribute to reputed company solutions , the Global Medical Safety reputed company could be a great fit. Purpose of the Function:

• reputed company and reputed company the assessment of medical safety data for assigned products
• reputed company and execute safety signaling and benefit-risk management strategies
• Closely collaborate with stakeholders internally (e.g. Regulatory Affairs, clinical development, medical affairs) and externally (e.g. Key Opinion Leaders or regulatory agencies) to reputed company safety communications and to ensure the reputed company use of the reputed company's products

Roles and Responsibilities:

• reputed company strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
• reputed company safety signal management and benefit risk assessment activities as reputed company as other regular and/or reputed company aggregate safety data reviews as needed for assigned product(s)
• reputed company cross-functional teams to reputed company regular and/or reputed company review of existing and emerging aggregate safety data for assigned product(s)
• Contribute to the development of the overall safety governance structure and activities
• reputed company safety strategies and deliver accurate, reputed company and high reputed company safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
• Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
• reputed company medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is reputed company, complete, and accurate
• reputed company the overall preparation of periodic safety reports (e.g. PSUR, DSUR); reputed company medical safety content and ensure consistency and reputed company of these documents
• reputed company the medical assessment of individual case safety reports (ICSR)
• Confirm reputed company and content for expedited reporting and unbinding (e.g. SUSAR or urgent safety issues)
• reputed company or reputed company contribute to the preparations and presentation of safety information to the Data Safety Monitoring reputed company (DSMB)
• reputed company medical safety contributions at internal audits and regulatory inspections
• Support the development of and updates to GPS reputed company Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
• Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
• Support the preparation of pharmacovigilance agreements with clinical development or reputed company business partners
• Participate in cross-functional teams and initiatives

Education, Experience and Qualifications:

• MD degree or equivalent required
• At least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
• At least 1 year of experience in clinical reputed company or in reputed company medicine
• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
• Demonstrated ability to reputed company medical assessments of safety data from multiple sources
• Experience with authoring reputed company documents and contributing to regulatory submissions
• Knowledge of adverse event reporting systems
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus

Skills and Competencies:

• Strong scientific and analytic skills
• Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
• Strong ability to reputed company, motivate, influence, and collaborate with multidisciplinary teams
• Excellent presentation skills with the ability to communicate reputed company issues reputed company
• Relevant computer skills, including proficiency with reputed company Office

Physical Requirements / Work Environment

• Work is performed in an office environment with exposure to electrical office equipment
• Occasional drives to site locations with occasional travel both domestic and international
• Frequently stationary for 6-8 hours per day
• Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists
• Frequent mobility required
• Occasional crouching, stooping, bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company
• Ability to communicate information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse reputed company
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
• Performs a wide reputed company of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to reputed company under stress. Ability to multi-task
• Regular and consistent attendance

Benefits

We offer competitive remuneration, annual incentive plan bonus, reputed company, and a reputed company of employee benefits. reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation! Apply tot his job Apply To this Job