Associate Director, Safety Analysis Scientist

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Product Safety

Product Safety Risk Management

Scientific/Technology

Horsham, Pennsylvania;
Raritan, New Jersey;
Titusville, New Jersey

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We are searching for the best talent for an Associate Director, Safety Analysis Scientist to be located in Horsham, PA;
Raritan, NJ; or Titusville, NJ.

Purpose: The Associate Director (AD), Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), the AD is responsible for the preparation of scientific safety analyses and evaluations 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 with 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 contribute to key safety and clinical documents. They will have in-depth product knowledge, serve as product point of contact, and 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). They will link discussions to content and consistently deliver high-quality results with minimal guidance, building alliances and independently influencing other safety partners to shape strong decisions/outcomes.

You Will Be Responsible For

• Leading safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other partners as necessary, data retrieval, data analysis, report writing, and report revision.
• Ensuring high-quality safety evaluations and reports with minimal comments from partners and minimal revisions required.
• Providing input and review of key regulatory or clinical documents as appropriate.
• Demonstrating leadership in the SMT and supporting the MSO.
• Supporting SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Leading proactive safety data reviews, if applicable, and forming a safety position across Global Medical Safety (GMS) for aggregate safety reports.
• Providing support for Health Authority interactions regarding safety and risk management, both written and verbal.
• Assuming responsibility for novel projects, bringing value and innovation without defined processes; may seek guidance from Directors for complex projects.
• Leading cross-functional training of relevant partners.
• Acting as product or process Subject Matter Expert (SME) for audits/inspections.
• Participating in, or leading, department and/or cross-functional initiatives.
• Exploring innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
• Assisting Directors in the creation, review and implementation of controlled documents and other related tools.
• Managing unscheduled reports within the Aggregate Report Calendar.
• Managing activities within smaller Therapeutic Areas, as applicable.
• Line-management of contractor positions within the team, as applicable.
• Acting as backup to TAL as needed (e.g., Director SAS TAL is unavailable).

Education

Qualifications / Requirements:

• Bachelor’s degree in Biomedical Science or a healthcare-related field is required. An advanced degree is preferred.

Experience And Skills

Required:

• 8+ years of relevant experience is required.
• Medical writing or Pharmacovigilance (PV) experience is required.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post-marketing and global safety health authority requirements is required.
• Ability to understand and analyze complex medical-scientific data from a broad range of fields is required.
• Ability to interpret and present complex data to determine benefit-risk impact is required.
• Excellent English verbal and written communication skills is required.
• Ability to plan work to meet deadlines and effectively balance multiple priorities is required.

Preferred

• Ability to…