Associate Director - Safety Data Sciences

The Associate Director - Safety Data Sciences (Remote) partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.

Responsibilities:

• Responsible for standard surveillance activities for a product's life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases and the literature
• Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources
• Independently analyzes data for signal assessment and leads preparation of materials of ad hoc regulatory safety requests using data from multiple sources
• Utilizes medical judgement to determine the impact of the safety issue on the product's benefit-risk profile
• Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes
• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan
• Independently authors, strategizes and review global aggregate safety reports in accordance with regulatory requirements and standard operating procedures
• Independently prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings
• Partners to lead safety-related activities/initiatives internal to PPS
• Proficient in pharmacovigilance regulations, guidelines, and company standard operating procedures
• In-depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues
• Mentors and trains new safety scientists

Requirements

Minimum Qualifications:

• Degree in Health Sciences (e.g. Pharmacy, Epidemiology, Nursing)
• 4+ years clinical/pharma or safety work experience (Bachelors candidates) OR 2+ years of clinical/pharma or safety work experience (Masters/Doctorate candidates)
• Pharmacovigilance experience

Other Required Skills:

• Knowledge of drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post-marketing support
• Demonstrates ability to connect regulatory obligations and safety science to support safety decision making
• Understanding of tools, standards and approaches used to efficiently evaluate drug safety
• Serves as a resource to cross-functional colleagues by soliciting input and providing recommendations and conclusions.
• Demonstrate effectiveness in working in a multi-disciplinary, matrix team situation
• Effective oral and written communication skills with ability to manage multiple projects simultaneously
• Microsoft Word and Excel Skills

Additional information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​
• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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