Senior Manager, PMS Management at Bristol-Myers Squibb

Kariya-shi, Aichi, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

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
Communication skills
Scientific writing skill
Ability of time management
Ability of CRO management
Leadership
Presentation skills (effective presentations in and outside the Company)
Negotiation skills with the Company and external parties
Organizational skills to manage multiple projects simultaneously
Demonstrates excellent attention to teamwork and initiative

Responsibilities

Creating PMS basic and execution plans
Drafting CRFs for PMS
Implementing PMS
Oversee the development, implementation and enforcement of PMS, including data collection, analysis and summary of results
Educating sales staffs regarding PMS
Creating and reviewing a J-PSUR (surveillance part)
Establish proper collection of safety information from HOCs
Creating and review answer to inquiry which will be submitted to the Japanese Regulatory Authority
Prepare and revise local SOP related and PMS(GPSP)
Contribute to establish and maintain good relationship with regulatory agency
Continuously improve overall work process
Selection of CRO
Managing CRO’s operation
Auditing CRO’s operation
Requesting improvement of CRO’s operation, if needed
Support development of strategic plans for safety differentiation of BMS KK product
Plan and implement training of BMS KK staff on PMS
Planning and implementing surveillances
Managing operation of surveillances
Cooperating with CROs and HOCs closely
Managing surveillance as a therapeutic area

Skills

Post Marketing Surveillance

Pharmacovigilance

CRO Management

Auditing

SOP Development

CRF Drafting

Data Analysis

Regulatory Reporting

J-PSUR

Safety Data Collection

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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