PV Manager-00000ATO
Description
1. In compliance with local regulations and company requirement, make medical review of all reported study SAE and marketed AEs
a) Ensure all received initial/follow up AE/SAEs timely reported to HA, GMS as well as the third partner according to the requirement of regulations, policies and PV agreements.
b) Ensure follow up the related AEs and report the additional information to HA, GMS and third partner according to the timeline.
2. Perform the medical assessment and involve in product risk management activities
a) Evaluate, identify, analyze potential the drug safety issue and concerns and may well interpret to the stakeholders
b) Make labeling safety review and recommendation to project team
c) Report the risk summary and assessment to the line manager or PV director if needed, lead, finalize and follow up the product risk management process and make proper drug safety recommendation or solution both from technical level and strategic business perspective.
3. As a liaison/point of contact, coordinate and work with all pertinent functions/department, support/execute safety strategy and plan on particular drug development stage
4. Be responsible for AEPQC training to external and internal stakeholders
a) Organize, perform and check the all AE PQC trainings (PV knowledge, product knowledge, regulations, guidelines, SOPs and WIs)
b) Organize, provide and perform the AE/PQC training for all XJP employees, new comers in AE reporting orientation by the different approaches
c) Be responsible for providing the AEPQC training to the external and support PV related inspection and CAPA follow up.
5. Provide safety expertise in local/regional medical safety culture, healthcare delivery system, and practice, and liaison with external vender/ research unit as needed to make sure well implementation of China R&D drug safety strategy
6. Support department head/line manager to identify areas of unmet safety related needs as regards local specifics (for e.g. China population-specific etc)
7. Support department head/line manager to identify areas of risk (for the PV system, policy, product, etc) due to heterogeneity of approaches
8. Provide assistance to safety department head in follow up of key safety issues arising, assistant in gather data, interpreting local medical practice; Be responsible for providing assistance in safety regulatory applications and product life cycle management and in the management of key stakeholders relationship with scientific safety knowledge
9. Provide technical support in safety information handling and product information management, and solve complexity information issues with standard Q&A, work with business partner to manage potential crisis related to product safety
Qualifications
Technical Skill Requirement:
1. Understanding of pharmacovigilance internal and external requirement and environment including scientific, methodological and regulatory aspects
2. Relevant drug safety knowledge and experience at least 2-3 years
3. Documentation management experience
4. Effectively communicating timeline, resource and other issues that have e.g. regulatory compliance
5. Understanding ICH/GCP and PV scientific basis for therapeutic or drug induced diseases. Effective interactions with key subject matter experts.
6. Experience in handling product information, database migration or generating/maintain/updating standard Q&A for product information
Qualifications:
1. Degree/Advanced degree in clinical medicine or pharmacy.
2. Drug safety experiences in PV or clinical research or drug development in international pharmaceutical companies at least for 2-3 years
3. Good problem solving and decision making skill
4. Strong interpersonal skills, with a demonstrated ability to foster team work
5. Ability to manage discussions and decision making
6. Excellent communication, conflict management and negotiation skills
7. Good oral and written English/Chinese communication skill
8. Opening, optimistic and easy going personality
9. Good computer application skills.
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job: Drug & Product Safety Science
Description
1. In compliance with local regulations and company requirement, make medical review of all reported study SAE and marketed AEs
a) Ensure all received initial/follow up AE/SAEs timely reported to HA, GMS as well as the third partner according to the requirement of regulations, policies and PV agreements.
b) Ensure follow up the related AEs and report the additional information to HA, GMS and third partner according to the timeline.
2. Perform the medical assessment and involve in product risk management activities
a) Evaluate, identify, analyze potential the drug safety issue and concerns and may well interpret to the stakeholders
b) Make labeling safety review and recommendation to project team
c) Report the risk summary and assessment to the line manager or PV director if needed, lead, finalize and follow up the product risk management process and make proper drug safety recommendation or solution both from technical level and strategic business perspective.
3. As a liaison/point of contact, coordinate and work with all pertinent functions/department, support/execute safety strategy and plan on particular drug development stage
4. Be responsible for AEPQC training to external and internal stakeholders
a) Organize, perform and check the all AE PQC trainings (PV knowledge, product knowledge, regulations, guidelines, SOPs and WIs)
b) Organize, provide and perform the AE/PQC training for all XJP employees, new comers in AE reporting orientation by the different approaches
c) Be responsible for providing the AEPQC training to the external and support PV related inspection and CAPA follow up.
5. Provide safety expertise in local/regional medical safety culture, healthcare delivery system, and practice, and liaison with external vender/ research unit as needed to make sure well implementation of China R&D drug safety strategy
6. Support department head/line manager to identify areas of unmet safety related needs as regards local specifics (for e.g. China population-specific etc)
7. Support department head/line manager to identify areas of risk (for the PV system, policy, product, etc) due to heterogeneity of approaches
8. Provide assistance to safety department head in follow up of key safety issues arising, assistant in gather data, interpreting local medical practice; Be responsible for providing assistance in safety regulatory applications and product life cycle management and in the management of key stakeholders relationship with scientific safety knowledge
9. Provide technical support in safety information handling and product information management, and solve complexity information issues with standard Q&A, work with business partner to manage potential crisis related to product safety
Qualifications
Technical Skill Requirement:
1. Understanding of pharmacovigilance internal and external requirement and environment including scientific, methodological and regulatory aspects
2. Relevant drug safety knowledge and experience at least 2-3 years
3. Documentation management experience
4. Effectively communicating timeline, resource and other issues that have e.g. regulatory compliance
5. Understanding ICH/GCP and PV scientific basis for therapeutic or drug induced diseases. Effective interactions with key subject matter experts.
6. Experience in handling product information, database migration or generating/maintain/updating standard Q&A for product information
Qualifications:
1. Degree/Advanced degree in clinical medicine or pharmacy.
2. Drug safety experiences in PV or clinical research or drug development in international pharmaceutical companies at least for 2-3 years
3. Good problem solving and decision making skill
4. Strong interpersonal skills, with a demonstrated ability to foster team work
5. Ability to manage discussions and decision making
6. Excellent communication, conflict management and negotiation skills
7. Good oral and written English/Chinese communication skill
8. Opening, optimistic and easy going personality
9. Good computer application skills.
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job: Drug & Product Safety Science