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R&D- PSPV - Senior PV Manager - SH
Job in
Virginia, St. Louis County, Minnesota, 55792, USA
Listed on 2026-02-02
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-02-02
Job specializations:
-
Healthcare
Healthcare Management
Job Description & How to Apply Below
Role Summary
Be responsible for safety risk management related to specify therapeutic areas (I & I) for product under development and marketed in CHINA
Responsibilities- 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
Position Requirements
10+ Years
work experience
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