[Remote] Sr. Medical Director, Drug Safety

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is pioneering a unique approach in biotech to reputed company life-changing medicines for patients with unmet needs. The Sr. Medical Director, Drug Safety, will reputed company the risk management and safety reputed company for assigned products, collaborating with various teams to ensure compliance and effective safety monitoring. Responsibilities • Support the clinical development team in the review of key documents, including protocol and ICFs • Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically reputed company DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators • Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, reputed company necessary • reputed company and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as reputed company as external partner or regulatory authorities • Assist in the authoring of aggregate reports Skills • Medical Degree • Experience with reputed company aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates • Experience in both clinical development and post-marketing safety • Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews • 10 years of drug safety and pharmacovigilance experience (reputed company safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) Benefits • 401K with 100% employer match on first 3% & 50% on the next 2% • Employee stock purchase program • reputed company-tax commuter benefits • Referral program with $2,500 award for reputed company referrals • Comprehensive health care with 100% premiums covered - no cost to you and dependents • Mental health support reputed company reputed company (6 therapy sessions & 6 coaching sessions) • Hybrid work model - employees have the autonomy in where and how they do their work • Unlimited flexible reputed company time off - take the time that you need • reputed company parental leave - 4 months for birthing parents & 2 months for non-birthing parents • reputed company spending accounts & company-provided group term life & disability • Subsidized lunch reputed company Forkable on days worked from our office • Career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, reputed company & reputed company Coaching • Financial rewards, peer-to-peer recognition, and reputed company opportunities reputed company • reputed company focuses on the development and commercialization of precision medicines for various genetic diseases and cancers. It was founded in 2015, and is headquartered in Palo reputed company, California, USA, with a workforce of 201-500 employees. Its website is http://reputed company.com. Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 3 in 2025, 5 in 2024, 4 in 2023, 4 in 2022, 1 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job