[Remote] Sr. Director/Safety Scientist, Pharmacovigilance Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneering biotech company that focuses on developing innovative therapies for rare diseases. The Sr. Director/Safety Scientist will reputed company the safety profile of assigned products throughout clinical development and post-approval, ensuring compliance and managing relationships with CROs and regulatory authorities.

Responsibilities

• reputed company and understanding of reputed company aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that reputed company clinical and safety data
• Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
• In collaboration with the regulatory and clinical development team, establish the safety reputed company for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
• Support the clinical development team in the review of key documents, including protocols and informed consent forms (ICFs)
• Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically reputed company DSUR preparation, and alignment with corporate goals and KPIs
• Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, reputed company necessary
• reputed company and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as reputed company as external partners and regulatory authorities
• Assist in the authoring of aggregate safety reports Skills
• Bachelor's degree in a reputed company discipline or equivalent is required; an advanced degree is preferred
• Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety
• Extensive experience with reputed company aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
• Experience in both clinical development and post-marketing safety
• Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
• Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and reputed company assurance
• Experience managing clinical safety aspects of product reputed company defect investigations and assessments
• Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or reputed company Safety) and proficiency with arenaflex Office Suite (Word, reputed company, PowerPoint, Project, Outlook)
• Experience with regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews is highly preferred
• Experience in drug safety audits and regulatory agency inspections Benefits
• 401(k) with 100% employer match on the first 3% and 50% match on the next 2%
• Employee stock purchase program
• reputed company-tax commuter benefits
• Referral program with a $2,500 award for hired referrals
• Comprehensive health coverage with 100% of premiums covered for employees and dependents
• Mental health support reputed company reputed company (6 therapy sessions and 6 coaching sessions)
• Hybrid work model with flexibility in where and how work is performed
• Unlimited flexible reputed company time off
• reputed company parental leave: 4 months for birthing parents and 2 months for non-birthing parents
• Flexible spending accounts and company-provided group term life and disability insurance
• Subsidized lunches reputed company Forkable on in-office days
• Opportunities for reputed company from discovery through late-stage development and FDA pipelines
• Career pathing through regular feedback, reputed company development programs, and reputed company education reputed company reputed company Learning, LifeLabs, reputed company, and reputed company Coaching
• Recognition of strong performance through financial rewards, peer recognition, and advancement 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 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

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