Reporting to the Head of Pharmacovigilance, the Lead Pharmacovigilance (“PV”) Scientist will collaborate closely with the Head of PV to ensure Spark protects patients’ safety by providing safety support for products in various stages of clinical development and follow them through their lifecycle and commercialization. S/he will serve as lead for PV activities aligned to the strategy, goals and objectives of the Pharmacovigilance function in compliance with requisite global and local regulations and requirements.
Working in close collaboration with the Head of PV, s/he will serve as Secretary of the Safety Review Team(s) preparing meeting agendas and documenting meeting minutes, provide pharmacovigilance support to the Quality Compliance team for oversight of safety related issues, and partner cross-functionally with clinical, commercial, medical and regulatory departments.
The Lead PV Scientist will be responsible for leading and overseeing the pharmacovigilance systems and processes in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all products, across multiple therapy areas, from development through post-marketing.
Provide expert guidance, support, and execution of the operational aspects of PV for all products in clinical development and post-marketing. Serve as the internal point of contact for all matters relating to drug safety and pharmacovigilance, and will be the external liaison for Pharmacovigilance for global regulatory agencies and pharmacovigilance vendors.
S/he will provide input into the development of the strategy and direction of the global pharmacovigilance department to meet the organizational needs.
Spark is a diverse and fast-moving environment in which this individual must, among all the above listed responsibilities, be able to successfully:
• Develop, implement and maintain procedures and operations for all aspects of global drug safety activities. Provide input into a clearly defined safety strategy. Collaborate with the Head of PV to ensure the benefit-risk profile is established and communicated.
• In collaboration with the Head of PV provide oversight of the emerging safety profile of the product including signal detection and evaluation, benefit-risk evaluation and risk management, and help ensure that all significant signals or safety issues are escalated and addressed appropriately.
• Provide oversight and support maintenance of international pharmacovigilance processes.
• Design, implement and oversee best-in-class global systems for the collection, collation, evaluation and distribution of safety reports, preparation and submission of aggregate reports, data management, signal detection and risk
.• Liaise effectively with other R&D leaders to ensure the smooth flow of safety data and prioritization of safety-related activities.
• Contribute to the determination of any business risk related to the acquisition of new or existing products.
• Interface externally with extensive vendors (Global Pharmacovigilance, CROs, Medical Information, etc.), external Key Opinion Leaders, , independent researchers, consultants, scientific advisors and other key partners.
• Train new employees in overall pharmacovigilance and regulatory reporting.
• Lead and oversee the planning and development of PV risk management activities throughout product development, commercialization, and post-marketing commitments, and the development, implementation, revision and progress reports of risk management plans, as required by global health authorities. This includes safety review of protocols and ICFs, safety content of IB. Assist with lab and AE data review, associated clinical study reports. Lead PSUR/PBRER/PADER/DSUR strategy and timelines with key stakeholders and vendor. Support RMP and REMS reports as appropriate.
• Liaise with clinical study teams and/or medical monitor to oversee safety monitoring of clinical trials
• Review and provide input on departmental global Standard Operating Procedures (SOPs) and Work Instructions development, audits and inspection readiness.
• Prepare and ensure the timely planning and preparation of annual IND reports and aggregate safety reports, including PSURs, PBRERs, and PADERs.
• Maintain expert knowledge of US REMS, PMR/ PMC, and EU RMP, PASS development.
• Represent Spark in Regulatory Agency inspections and participate in regulatory agency meetings as required.
• Assist with development and management of global pharmacovigilance budget and resources.
Understanding the Business
• Knows the business and the mission-critical technical and functional skills needed to do the job; understands various types of business propositions and understands how businesses operate in general; learns new methods and technologies easily.
Making Complex Decisions
• Can solve even the toughest and most complex of problems; great at gleaning meaning from whatever data is available; is a quick study of the new and different; adds personal wisdom and experience to come to the best conclusion and solution, given the situation; uses multiple problem-solving tools and techniques.
Getting Work Done Through Others
• Manages people well; gets the most and best out of the people he/she has; sets and communicates guiding goals; measures accomplishments, holds people accountable, and gives useful feedback; delegates and develops; keeps people informed; provides coaching for today and for the future.
Managing Work Processes
• Is an effective process, work flow, and systems designer; is good at figuring out what to measure to track progress; sets up systems that can almost manage themselves; is a master at the effectiveness and efficiency of work systems; can quickly diagnose and fix a work flow problem; always looking for incremental process improvement.
Dealing with Trouble
• Fearlessly takes on all issues, challenges, and people; comfortably confronts and works through conflict; delivers negative feedback and messages without hesitation; deals promptly and fairly with problem performers; lets everyone know where they stand; thrives in crises and is energized by tough challenges; not afraid to make negative decisions and take tough action; challenges the status quo.
Evaluating and Deploying People Accurately
• Reads people accurately; can diagnose strengths, weaknesses, and potential; knows what skills are required to fill a job or role; hires the best.
Focusing on Action and Outcomes
• Attacks everything with drive and energy with an eye on the bottom line; not afraid to initiate action before all the facts are known; drives to finish everything he/she starts.
• Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.
Managing Diverse Relationships
• Relates well to a wide variety of diverse styles, types, and classes; open to differences; effective up, down, sideways, inside, and outside; builds diverse networks; quick to find common ground; treats differences fairly and equitably; treats everyone as a preferred customer.
• Is skilled at getting individuals, teams, and an entire organization to perform at a higher level and to embrace change; negotiates skillfully to achieve a fair outcome or promote a common cause; communicates a compelling vision and is committed to what needs to be done; inspires others; builds motivated, high-performing teams; understands what motivates different people.
• Healthcare Degree required
• Generally has 10+ years of relevant experience, with at least 5-7+ years experience in Pharmacovigilance/drug safety serving in a PV scientist or similar role (both pre- and post-marketing) in a pharmaceutical/biotechnology company or CRO.
• Experience in project management and Safety Review Team meeting management is preferred
• Detailed knowledge of the use of drug safety databases, individual case processing experience and practical expertise with MedDRA.
• Demonstrated experience in analyzing and interpreting medical and scientific data.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.