Safety Director Jobs

About The Position

Requirements

• Bachelor’s degree in a healthcare-related or biomedical science field and 11+ years of industry experience or equivalent.
• Medical writing or Pharmacovigilance (PV) experience.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post-marketing, as well as global safety health authority requirements.
• Ability to understand and analyze complex medical-scientific data across a broad range of disciplines.
• Ability to interpret and present complex data to determine benefit-risk impact.
• Excellent English verbal and written communication skills.
• Ability to interact effectively with stakeholders, including business partners.
• Ability to work in a matrix environment and demonstrate leadership skills.
• Ability to plan work to meet deadlines and handle multiple priorities effectively.
• Proficiency in Microsoft applications, including Word, Excel, and PowerPoint.
• Ability to independently influence, negotiate, and communicate with internal and external customers.

Nice To Haves

• Advanced degree in a healthcare-related or biomedical science field and 8+ years of industry experience or equivalent.
• Clinical experience.

Responsibilities

• Lead safety evaluations, including strategy discussions, stakeholder collaboration, data retrieval and analysis, report writing, and report revision.
• Ensure safety evaluations and reports are high quality and require minimal stakeholder comments and revisions.
• Provide input to and review key regulatory or clinical documents, as appropriate.
• Demonstrate leadership in the Safety Management Team (SMT) and support the Medical Safety Officer (MSO).
• Support SMT activities, including preparing and presenting data, compiling meeting minutes, and updating signal-tracking information.
• Lead proactive safety data reviews, where applicable, and establish a safety position across Global Medical Safety (GMS) for use in aggregate safety reports.
• Support written and verbal Health Authority interactions related to safety and risk management.
• Take responsibility for novel projects, creating value and innovating where processes are not defined; seek Director guidance for complex projects as needed.
• Lead cross-functional training for relevant stakeholders.
• Serve as a product or process Subject Matter Expert for audits and inspections.
• Participate in or lead departmental and cross-functional initiatives.
• Identify innovative ways to present data, prepare reports, and improve efficiencies within assigned programs.
• Assist Directors with creating, reviewing, and implementing controlled documents and related tools.
• Manage unscheduled reports within the Aggregate Report Calendar.
• Manage activities within smaller Therapeutic Areas, as applicable.
• Line-manage contractor positions within the team, as applicable.
• Act as backup to the Therapeutic Area Lead when needed.
• Provide oversight of other team members’ deliverables, such as complex reports, as needed.

Benefits

• Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility to participate in the Company’s long-term incentive program.
• Vacation: 120 hours per calendar year, subject to policy and date-of-hire terms.
• Sick time: 40 hours per calendar year, with specified higher allotments for employees residing in Colorado or Washington, subject to policy and date-of-hire terms.
• Holiday pay, including floating holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of the birth, adoption, or foster care of a child.
• Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
• Caregiver leave: 80 hours in a 52-week rolling period.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time off: 80 hours per calendar year.