Manager, Safety Analysis Scientist
About The Position
This role is for a Manager, Safety Analysis Scientist (SAS) within Innovative Medicine, specifically focusing on Oncology. The position is available across multiple locations in the US (Horsham, PA; Raritan, NJ; Spring House, PA; Titusville, NJ) and is a hybrid role requiring three days on-site per week. The Manager SAS provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), they are responsible for preparing scientific safety analyses and evaluations crucial for regulatory compliance and safety-related decisions for both marketed and developing products. The role involves supporting Product Safety Management Teams (SMTs), collaborating with cross-functional safety partners to define product safety strategies, conducting safety analyses, proactively reviewing safety data, interpreting safety information, and making recommendations to support SMT deliverables. The Manager SAS will also assist the MSO with SMT activities and contribute to key safety and clinical documents. They will possess in-depth product knowledge, serve as a product point of contact, and provide mentoring and oversight for other team members on complex reports. The role requires independent functioning with moderate guidance, the ability to link discussions to content, and deliver quality results with minimal guidance. Building alliances and influencing other safety partners to shape decisions is also a key aspect of this position.
Requirements
- Bachelor’s Degree Required: Healthcare-related or Biomedical Science (9+ years of industry experience or equivalent).
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
- Medical writing or PV experience.
- Ability to understand and analyze complex medical-scientific data from a broad range of sources.
- 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 influence, negotiate, and communicate with both internal and external customers.
Nice To Haves
- Advanced Degree Preferred: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent).
- Clinical experience.
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-to-moderate comments from stakeholders and minimal-to-moderate revisions required.
- Provide support to AD SASs for novel projects without defined processes.
- Provide input and review to 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 GMS which can be leveraged for aggregate safety reports.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Contribute to cross-functional training of relevant stakeholders.
- Mentor other SASs on activities within the role.
- Participate in department and/or cross-functional initiatives and explore innovative ways of presenting data, preparing reports, and improving efficiencies.
- Assist in the creation, review and implementation of controlled documents and other related tools.
- Support audits/inspections.
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)).
- long-term incentive program.
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year
- 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/foster care of a child
- Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave - 10 days
- Volunteer Leave - 4 days
- Military Spouse Time-Off - 80 hours
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
