R&D - PSPV - (Senior) PV Manager - Shanghai

Main responsibilities include:

1. Be responsible for safety risk management related to specify therapeutic areas 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.

2. 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.

3. 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

About you

• Medical Doctor, Pharmacist, Health Sciences PhD, MPh or Master Degree.

• Minimum 8-10 years of experience in pharmacovigilance or industry. Experience with business development activities, licensing deals, or M&A transactions is highly recommended.

• Strategic Thinking: Capable of independently managing multiple priorities, applying intentional and rational thought to drive long-term success

• A strong leader and motivator, skilled in building networks and fostering collaboration within international cross-functional teams.

• Strong knowledge and Expertise in national (Pharmacovigilance) regulations and international regulations as well as industry standards, Drug administrative law, Vaccine administrative Law, GVP, GCP, China registration regulation, pharmacovigilance related regulation.

• Scientific ability on safety evaluation, e.gt, Literature assessment, evaluation of safety data analyses results.

• Strong project management capability.

• Proficiency in AI tools and digital technologies, and ability to leverage emerging AI solutions to drive business outcomes, enhance operational efficiency and compliance.

• Good command of English, both in verbal and in written. Competency equal to College English Test Band 6 or above.

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