Pharmacovigilance (PV) Associate I

WorldWide Patient Safety, Safety Evidence and Sciences / Submissions and Operational Excellence is responsible for ensuring global oversight centrally to fulfil regulatory obligations and deliver high quality regulatory documents to health authorities for safety aggregate reporting and conduct routine compliance monitoring of risk management. This function is also dedicated to collaborate effectively with cross-functional stakeholders with specific focus in WWPS to provide strategic and operational support across therapeutic areas for risk management, signal detection, safety management teams, dedicated support through portfolio strategy and management, to implement effective and distinct processes that are closely monitored for continuous process improvements with optimal technology solutions within safety and oversight and support to Local Market Patient Safety on additional risk minimization measures (aRMMs) implementation worldwide for BMS assets., Develop proficiency related to Safety Management Team (SMT) and Safety Data Review (SDR) activities and processes and support Medical Safety Assessment Physicians (MSAP), Patient Safety Scientist, SDRTeams, and Safety Management Team (SMT) programs.

Position Responsibilities

Applies medical, life science and general scientific knowledge and expertise to independently create and manage plans for designated projects.

Signal Detection Support

• Attends SDR Meetings as schedule permits.


• Collaborate cross-functionally (e.g., Pharmacovigilance Center of Excellence PvCoE, Clinical and Data Management)


• Signal log entry and signal log report outputs.


• Execute literature searches, deliver output, and retrieve full-text articles, as applicable, applying critical thinking and independent research skills to ensure the information is appropriate and usable. Liaise with literature vendor(s).


• Review Pharmacovigilance Agreements (PVAs) as it relates to signal reporting.


SMT Support

• Support Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross functional SMTs and assigned sub-teams, such as Safety Data Review (SDR) Teams.


• Builds cross functional relationships with SMT membership and stakeholders


• Create meeting materials for SMT and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.


• Identify post-meeting actions, and ensures responsibilities and timelines are assigned and met.


• Assess and appropriately elevate issues impacting key SMT activities, milestones, documents to the appropriate WWPS colleagues.


• Leads, plans, and organizes requirements and/or resources based on BoW and other upcoming tasks and activities for assigned product portfolio.


Support Administrative Activities

• Manage access, permissions and content related to SMT SharePoint Online and OneSafe SMT (Veeva Vault SafetyDocs).


• Manage study information received in PV mailbox.


• Maintain SMT membership lists, mail groups, and file shares.


• Manage MSAPSMT mailbox/meeting calendar for assigned product portfolio.


• Support of new hires.


Other Activities

• Work collaboratively with Clinical Safety Program Leads to successfully execute CSP-related activities for protocols, including tracking, reporting, querying, follow up in EDC system, etc. (TAO/RAVE).


• Participate in process improvement projects and implementation.


• Support preparation for regulatory inspections.


• Close safety-related health authority queries in Verity.


• Provide backup coverage to PV Associate II role, as needed., 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/ (https://careers.bms.com/eeo-accessibility) 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.


• Degree required; BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training., Basic knowledge of safety activities in drug development, medical concepts, and BMS products and landscape


• Sound critical thinking and problem-solving skills


• Strong organizational, facilitation, and interpersonal communication skills


• Intermediate medical writing skills and medical terminology


• Basic planning/project management skills (develop short range plans that are realistic and effective)


• Established skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)


Key Competency Requirements

• Good collaborative and communication skills with scientific subject matter.


• Attention to detail with scientific, analytical, and conceptual skills and the ability to reach reasoned conclusions.


• Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, post marketing reports, scientific literature and regulatory documents).


• Proficient in MS Word, Excel, PowerPoint, SharePoint Online, and Outlook.


• Ability to effectively work well with cross-functional teams


• Ability to independently manage a book of work (i.e., products/projects/programs) with a commitment to quality.


• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  
  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 .