Associate, Pharmacovigilance

2+ years

Not Disclosed

Hyderabad

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Working with Us

Challenging. Meaningful. Life-changing. These are not typical words associated with a job, but working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

At Bristol Myers Squibb, we recognize the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Division

Research and Development
Global Drug Development
Worldwide Patient Safety
Safety Evidence and Sciences
Submissions and Operational Excellence

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines through pharmacovigilance and pharmacoepidemiology deliverables. This includes single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and ensuring compliance with global regulatory requirements.

Position Summary

The Pharmacovigilance (PV) Associate I will support administrative and operational activities for Signal Detection (SD), Safety Data Review (SDR), Scheduled Aggregate Reports (SARs), Safety Management Team (SMT) system set-up, access support, data coordination, and tracking of actions.

Position Responsibilities

Signal Detection/Safety Data Review
- Generate and file data for signal detection and safety data review.
- Execute literature searches and retrieve and deliver full-text articles.
- Support and manage Safety Data Review Meetings (SDRMs) logistics.
Signal Documentation and Notifications
- Generate reports and upload into Signal Tracker.
- Perform quality checks (QC).
Safety Management Team (SMT)
- Create and manage SMT Membership List and Mail Group.
- Create and manage SMT File Share, SharePoint site, and Document Management System.
- Schedule routine meetings.
- Manage asset close-out and MSAPSMT mailbox/meeting calendar.
- Manage access, permissions, and content related to SMT OneSafe and SharePoint Online for assigned assets.
Scheduled Aggregate Report
- Obtain exposure data and update documents.
- Generate and file supporting data.
- Support literature searches and deliver full-text articles.
Document Compliance, Management, Support
- Transfer data into reports, format, query follow-up, and manage closing, filing, and tracking.
Other Activities
- Manage data received in PV mailbox.
- Update signal detection lists related to MedDRA upgrades.

Degree Requirements

BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training.

Experience Requirements

Must-Have Requirements:
- Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.
- Minimum of 2 years of professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience.
- Demonstrated understanding of global pharmaceutical drug development and lifecycles.
Ideal Candidates Would Also Have:
- Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes.
- Extensive experience in organizing, coordinating, and communicating data and information.
- Project or program management experience and/or qualifications.
- Experience working with diverse teams.

Key Competency Requirements

Working understanding of pharmacovigilance activities/processes and medical concepts.
Ability to manage timelines and quality of work using organizational and interpersonal communication skills.
Good collaborative and communication skills.
Attention to detail with scientific, analytical, and conceptual skills and the ability to reach reasoned conclusions.

Operational Skills

Technical Proficiency: Basic use of standard operational software and tools for automation.
Process Management: Understanding of current processes and ability to evaluate and suggest digital improvements.
Problem-Solving: Addresses straightforward problems with simple digital solutions.

Analytical Skills

Data Management: Processes and records data and information in structured computer-readable formats.
Critical Thinking: Identifies flaws and inconsistencies in data or business processes by considering the system-wide impact.
Data Analysis: Can perform basic data gathering and reporting using standard tools.

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 an inclusive culture, promoting diversity in clinical trials. 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 a diverse 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 assigned is determined by the nature and responsibilities of the 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 critical to collaboration, innovation, productivity, and a positive company culture.
Field-based and remote-by-design roles require the ability to physically travel to visit customers, patients, or business partners and attend meetings on behalf of BMS as directed.

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 before 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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