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Pharmacovigilance Lead- SDEAs
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jul 21
Reporting to the Head of Pharmacovigilance, the Pharmacovigilance (“PV”) Lead- SDEAs manages Safety Data Exchange Agreements (SDEA)/Pharmacovigilance Agreements (PVA) for contractual relationships with license business partners and acts as a key contact person for internal and external stakeholders, managing the relationship directly throughout the lifecycle of the agreement (creation/negotiation, implementation and maintenance) including compliance oversight.
The PV Lead- SDEAs will collaborate closely with the Head of PV to ensure Spark protects patients’ safety as the lead for SDEAs aligned to the strategy, goals and objectives of the PV function in compliance with requisite global and local regulations and requirements.
Spark is a diverse and fast-moving environment in which this individual must, among all the above listed responsibilities, be able to successfully:
Act as a PV contact point on all matters relating to SDEAs with license business partners, potentially including the handling of confidential information and negotiation of the agreements with commercial and co-development partners.
Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties.
Track and maintain oversight on all assigned SDEAs.
Communicate contractual obligations to internal stakeholders in a clear and comprehensive manner.
Apply standardized contract guidelines in-line with company polices and legal and regulatory constraints.
Ensure oversight and respect of contractual obligations with all internal and external parties for all SDEAs.
Ensure compliance with PV regulations, guidelines and industry practice.
Actively support audits and inspections.
Escalate issues utilizing governance models and standard communication plans involving business partners.
Liaise effectively with other R&D leaders and SDEA partners to ensure the smooth flow of safety data and prioritization of safety-related activities.
Lead and oversee the planning and development of PV risk management activities within SDEAs 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. Develop aggregate report strategy and timelines with key stakeholders and vendor. Support RMP and REMS reports as appropriate.
Develop, implement, and maintain procedures and operations for SDEA-relevant aspects of global drug safety activities. Provide input into a clearly defined safety strategy.
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.
Maintain expert knowledge of global, and local-specific, PV requirements.
Represent Spark in Regulatory Agency inspections and participate in regulatory agency meetings as required relevant to the role.
Assist with development and management of global pharmacovigilance budget and resources.
As part of the PV team,
Support PV team activities for other programs, if/as needed and time allows, to ensure all PV responsibilities are fulfilled.
Provide input into the development of the strategy and direction of the global PV department to meet the organizational needs.
Demonstrated strength with project management and collaboration skills.
Creativity in problem identification and resolution and motivated self-starter with a relentless drive to accomplish company goals and objectives. A can-do attitude is a must.
A demonstrated commitment to creating a culture of partnership and collaboration.
Strong communication and influence skills, with the ability to inspire confidence and work successfully with varied audiences. Excellent writing skills.
Flexible to changing priorities and challenging timelines.
Bachelor’s Degree required
Healthcare Degree preferred
Experience with life-cycle of SDEAs (development, implementation and compliance oversight) for an array of business set-ups including manufacturer, Distributor, Supplier, Warehouse, Local MAH (per local legislation) Local Representative (delegation of PV activities), License-Out, License, Co-Development and Divestment.
Generally, has 10+ years of relevant experience, with at least 5 years’ experience in Pharmacovigilance/drug safety serving as an SDEA manager or similar role (both pre- and post-marketing) in a pharmaceutical/biotechnology company or CRO
Detailed knowledge of the drug development processes and pharmacovigilance obligations including GVP, ICSR Reporting, aggregate reports (DSUR, PSUR/PBRER, PADER), RMP and Safety Surveillance activities. Knowledge of the use of drug safety databases and practical expertise with MedDRA.
Experience with global drug safety regulations (i.e., FDA, EMA, etc.) and working in a global pharmaceutical Pharmacovigilance department.
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.
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