Associate, Pharmacovigilance

0-1 years

Not Disclosed

Hyderabad

12 March 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

About the job

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually 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 get 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.

Bristol Myers Squibb recognizes 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.

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Position Summary

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

Position Responsibilities

Apply medical, life science and general scientific knowledge and expertise to effectively support the following:

Signal Detection/Safety Data Review

Signal Detection Support

Generate and file standard signal detection reports
Execute literature searches and retrieve and delver full-text articles, as applicable
File additional signal detection data for routine safety data review
Schedule routine Safety Data Review Meetings (SDRMs)

Signal Documentation

Generates the LEAD report and upload into Signal Tracker
Provide Pharmacovigilance Agreement (PVA) as needed

Safety Management Team

Create and manage SMT Membership List
Create and manage SMT Mail Group
Create and manage SMT File Share (i.e., Safety Data Review Folder)
Create and manage associate systems (i.e., Sharepoint [SP] site, OneSafe)
Schedule routine meetings
Manage asset close out
Manage MSAPSMT mailbox/meeting calendar
Manage access, permissions and content related to SMT OneSafe and SharePoint Online for assigned assets.

Scheduled Aggregate Report

Generate and file supporting data
Support literature searches and deliver full-text articles

Other Activities

Manage data received in PV mailbox.
Close safety-related health authority queries in Verity.
Support data tracking, reporting, and querying follow up

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 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 the organization, coordination, and communication of data and information.
Project or program management experience and/or qualifications.
Experience in working with diverse teams.

Key Competency Requirements

Working understanding of pharmacovigilance activities/processes and medical concepts.
Working understanding of team priorities and milestones.
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.
Possess good working skills in MicroSoft Office (or equivalent) programs (e.g., Word, Excel, PowerPoint, SharePoint Online, Outlook)
Understanding of scientific data

#HYDDD

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, 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

Responsibilities

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 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 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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