Safety & PV Manager/药物警戒经理社

面议

市辖区7年及以上

发布时间：2023-09-06

职位描述

Job Summary (Primary function)
The Local PhV Manager will be responsible for supporting general Global PhV and Risk Management activities from a local perspective for PhV functions. The manager will have a focus on clinical and post-marketed related tasks for Incyte products and programs. The position will be responsible for ensuring global PhV needs as required and reporting requirements. The role will be project and clinically oriented and responsible for supporting various global team initiatives within Pharmacovigilance (GPRM). Additionally, the Local PhV Manager (contractor) will help to streamline and standardize collaboration with multiple Incyte departments as applicable, assisting with coordinating relevant PhV activities for all Incyte compounds in the local territory.


Essential Functions of the Job (Key responsibilities)
· Provide regulatory intelligence, authoring, guidance and support for any local requirements for Aggregate Safety Reports (DSURs, PBRERs), RMPs, Signal Notification, and Literature review in collaboration with the Global Risk Management & Safety Surveillance (GRMSS) Physician, Scientists and Aggregate Reports team as per regional regulatory requirements (for example, China GVP) with awareness of necessary related global requirements.


· Work with GRMSS to identify, create and execute Risk Minimization measures as per regional requirement.


· Awareness of Safety Governance Team meeting minutes and dissemination among other regional Incyte staff as needed


· Confirmation of the current regional and local Reporting Requirements/Safety Regulatory Intelligence for China for the Safety Reporting Plans for all local/global trials in the territory.


o Confirm the content of the SRP appendix A template on China requirements,


o Confirm the same for the other countries currently covered by our Partners in China


o Confirm whether there are obligation differences in China by provinces/regions /etc…,


o Anticipate/Proactively and inform GPRM on very specific obligations, such as the Hainan Pilot Zone, and any other local Zones.


o For Clinical Trials:
-Confirm the Global/Local sponsors’ responsibilities (sponsor versus IND holder)


-Confirm whether the sponsor must be the party performing submission to NMPA or not (topic brought by InnoCare)


-Describe the various Reporting Requirements for Sites and CECs (since it varies per sites and CECs),


-Provide further details on the gap-packs as we received requests for such reports in parsaclisib studies,


-Explain and confirm all relevant regulatory bodies existing in China (HGRAC, CDE, NHC, any others?)


o For IIRs in China: Determine who submits to NMPA, confirm whether it can be the drug distributor and/or the IIR site depending on partnerships


o For Post-Marketing requirements: Determine the scope of reporting based on contractual obligations with partners


o For Periodic Safety reports (PSR): Determine all required PSRs in the region, and determine when study specific LLs are required (eg. INCB 50465-313/304)


o For programs in between pre and post-marketing (e.g. EAPs, CUPs, NPS, donation requests):


Determine what exists in China, with relevant obligations, to better assist GPRM to anticipate when such programs are to be conducted in the region for global reporting obligations


· Support the PhV compliance and GPSM teams within GPRM in making determinations when discrepancies appear with local regulations and reporting rules between Partners in these regions. The GPRM global team will rely on the local PhV manager to ensure compliance with china reporting rules.


· Master Service Agreements (MSA) with Partners in China . The local PhV Manager should:


· Develop a strong understanding of MSA content to be able to answer GPRM questions when drafting the PVAs (Pharmacovigilance Agreements between Incyte and partners in China).


· Obtain a clear understanding of the scope (what each party can do or cannot do, what is allowed and what is not as per MSA) to be able to clarify the extent of the role and responsibilities of the Business Partners in China and Incyte,


· Provide clarity on the Opt-in and Opt-out decisions in China with the partners, and specify whether this is applicable to all PVAs or which ones,


· Clarify the type of studies that can be operated under an MSA/PVA (Joint collaborative, etc.),


· Ensure the MSA has a PhV section or has reference to PhV tasks (standardize PhV wording in MSA),


· Ensure PVAs are in line with the content of the corresponding MSA (i.e., which party should report to NMPA, or does the business partner have the capability of reporting to NMPA, etc... ),


· Have a good understanding of the differences between the Master Agreements we have with other future Partners in this region, as applicable.


· PhV Agreement. The local PhV manager should:


· Inform global team on what should be included by default in the PVAs for China activities.


· Perform a verification of the PVA content during or after review of the draft PVA impacting China partners


Qualifications (Minimal acceptable level of education, work experience, and competency)


· License’s degree in a Science or Healthcare related discipline, or equivalent.


· Minimum of 3 years Pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.


· Proficiency using safety database systems (Argus experience preferred).


· General knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.


· Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).


· Excellent ability to work effectively within a team environment.


· Advanced organizational, time management, and problem-solving skills.


· Ability to create and deliver presentations.


· Excellent verbal and written communication skills.


· Fluency in written and verbal Engli********************

其他要求

招聘人数：1人
职能类别：药物安全/药物警戒PV

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