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Position Summary

Responsible for:

• Planning and implementing surveillances
• Managing operation of surveillances
• Cooperating with CROs and HOCs closely
• Managing surveillance as a therapeutic area

Duties/Responsibilities

Post Marketing Surveillance

1. Creating PMS basic and execution plans

2. Drafting CRFs for PMS

3. Implementing PMS

4. Oversee the development, implementation and enforcement of PMS, including data collection, analysis and summary of results.

5. Educating sales staffs regarding PMS

6. Creating and reviewing a J-PSUR (surveillance part)

7. Establish proper collection of safety information from HOCs.

8. Creating and review answer to inquiry which will be submitted to the Japanese Regulatory Authority.

9. Prepare and revise local SOP related and PMS(GPSP).

10. Contribute to establish and maintain good relationship with regulatory agency

11. Continuously improve overall work process

Cooperation with CRO

1.     Selection of CRO

2.     Managing CRO's operation

3.     Auditing CRO's operation

4.     Requesting improvement of CRO's operation, if needed.

Commercialization support and liaison to other functions

1.     Support development of strategic plans for safety differentiation of BMS KK product.

2.     Plan and implement training of BMS KK staff on PMS.

Reporting Relationship

Report (at a minimum )to:

• Senior Manager(EG-130), PMS Management , Patient Safety-Japan

Qualifications

Specific Knowledge, Skills, Abilities:

1. Communication skills

2. Scientific writing skill

3. Ability of time management

4. Ability of CRO management

5. Leadership

6. Presentation skills(effective presentations in and outside the Company)

7. Negotiation skills with the Company and external parties.

8. Assist Senior Manager(EG-130)

Education/Experience/ Licenses/Certifications:

Over 8 years of experience in PMS or related work experience.

Experience of re-examination applications and its inspections (twice or more are preferable).

Pharmaceutical and Scientific knowledge of SOP, GPSP.

Organizational skills to manage multiple projects simultaneously.

Demonstrates excellent attention to teamwork and initiative.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: 

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