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Sanofi · 4 days ago

R&D- PSPV - Senior PV Manager - SH

Shanghai, VA

Full-time

Onsite

Senior Level

Sanofi is a global healthcare company focused on transforming the practice of medicine. They are seeking a Senior PV Manager to be responsible for safety risk management in specific therapeutic areas for products under development and marketed in China.

Health CareLife SciencePharmaceuticalTherapeutics

H1B Sponsor Likely

Responsibilities

Be responsible for safety risk management related to specify therapeutic areas (I & I) for product under development and marketed in CHINA

Setting safety strategy of related TA products, i.e

Provide and accumulate TA-specific PV expertise, contribute PV expert to support new launch

Provide safety input to studies by reviewing study outline, protocol and CSR, etc

As medical reviewer for safety submission documents to health authority

Develop and communicate monthly safety review report

Give PV input in due diligence for business development purpose

Help GSO to understand local regulation requirements

Validate Chinese translation of EU RMP, DSUR, CSR, CCDS, Risk control plan, etc. for CTA and CTW/NDA

Support to prepare slides and other submission dossier during CTA

Work out China risk management plan to specific products, and lead the cross-functional team to implement, manage the product safety risks in China market

Serve as contact person, provide valuable inputs to partners from safety perspective (e.g. safety management plan) to support pipeline development and clinical study implementation

Implement and assessment as well as risk management to optimize benefit/risk profile of related products

Continuous and efficient evaluation of available safety information at local level

Drive proactive implementation of risk management in accordance with regulation requirement

Support CSH on signal detection in responsible TA and communicate the potential safety signal with GPV

Write local Periodic Safety Report if applicable

Management of safety related queries from external and internal stakeholders

Give PV input for regulatory related activities, e.g. labeling, license renewal, new application

Support CSH to response safety queries from HA, HCP and other external customers

Involved in various projects as PV expertise for responsible TA or products

Provide input on cross-functional ad-hoc teams set up to address urgent and important safety issues

Qualification

Safety risk managementPV expertiseRegulatory submissionsChinese translation validationSignal detectionPeriodic Safety Report writingCross-functional collaboration

Required

Be responsible for safety risk management related to specify therapeutic areas (I & I) for product under development and marketed in CHINA

Setting safety strategy of related TA products