Associate Director, Safety Analysis Scientist
About The Position
This role provides scientific expertise and leads the safety assessment of assigned products. The Associate Director (AD) Safety Analysis Scientist (SAS), in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development. The AD SAS will support Product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required. The AD SAS will assist the Medical Safety Officer (MSO) with activities related to the SMT and with contributions to key safety and clinical documents. The AD SAS will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports). The AD SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. The AD SAS will quickly build alliances and be able to independently influence other safety partners to shape strong decisions/outcomes.
Requirements
- Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent).
- Medical writing or Pharmacovigilance (PV) experience required.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
- Ability to understand and analyze complex medical-scientific data from 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 effectively interact with stakeholders, including business partners.
- Ability to work in a matrix environment, proven leadership skills.
- Ability to plan work to meet deadlines and effectively handle multiple priorities.
- Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
- Ability to independently influence, negotiate and communicate with both internal and external customers.
Nice To Haves
- Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent).
- Clinical experience preferred.
- Oncology experience preferred.
Responsibilities
- Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
- Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
- Provide input and review of key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Lead proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Assume responsibility for novel projects, create value and innovate without defined processes.
- May seek guidance from Directors (i.e., SAS TAL) for complex projects.
- Lead cross-functional training of relevant stakeholders.
- Act as product or process Subject Matter Expert (SME) for audits/inspections.
- Participate in, or lead, department and/or cross-functional initiatives.
- Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
- Assist Directors in the creation, review and implementation of controlled documents and other related tools.
- Management of unscheduled reports within the Aggregate Report Calendar.
- Management activities within smaller Therapeutic Areas, as applicable.
- Line-management of contractor positions within the team, as applicable.
- Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable).
- Oversight of deliverables by other team members (e.g., complex reports), as needed
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
