Senior Pharmacovigilance Scientist, US remote

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Overview

Reporting into the Senior Director, Drug Safety and Pharmacovigilance (PV), the Senior Pharmacovigilance Scientist supports the operational and medical components of pharmacovigilance activities including surveillance activities providing scientific/clinical pharmacovigilance expertise with focus on the identification, evaluation, and management of safety risk for POINT Biopharma products.

Objectives

• Liaise with other relevant functional areas both within and outside of Drug Safety and PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
• Collaborate with cross-functional partners to evaluate and actively manage risks, in accordance with global regulatory frameworks, to ensure patient safety.
• Core surveillance activities and signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.
• Demonstrate outstanding knowledge of local and global health authority requirements.
• Support Drug Safety and PV in the maintenance of a highly effective safety organization in full compliance to worldwide regulations.
  
  

Accountabilities

• Liaise with the cross functional team to gather and provide input for appropriate sections of critical clinical documents (e.g., protocols and amendments, ICFs, IBs, RSIs, CSRs).
• Perform routine and ad hoc safety surveillance activities such as signal detection, literature search and risk management to support the safety physician on one or more programs.
• Review and contribute to development of periodic safety reports (e.g. DSUR)
• Provide support to PV operations in ICSR quality oversight and work with QA to maintain a state of high PV inspection readiness
• Contribute to activities in the monitoring of compliance with regulations and development of internal SOPs related to PV function.
• Represents PV department on clinical development teams, as assigned.
• Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations and guidelines.
  
  

Requirements

• Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, PharmD) or equivalent degree qualification is a strong requirement
• Advanced degree such as a Master’s is preferred
• Minimum of 5-8 years of relevant pharmaceutical industry experience
• Experience in case management preferred
• Experience in contributing to and reviewing aggregate safety reports (safety surveillance activities, PBRERs, DSURs, etc.)
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
• Experience in signal detection, evaluation, and management
• Proficiency in English both written and spoken and excellent written and verbal communication skills with the ability to interact across multiple functions
• Understanding of GCP/ICH, FDA regulations and guidelines. Working knowledge of global PV Regulations
  
  

Competencies

• Working understanding of medical concepts and familiarity with safety activities in drug development as well as global safety health authority requirements.
• Strong knowledge of clinical development process.
• Demonstrated ability to work effectively either independently or collaboratively in a team environment, both internally or with external colleagues
• Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or 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)
• Attention to detail along with strong 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).
• Possess good working skills in MS Word, Excel, and PowerPoint, including statistics
  
  

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
• Most importantly, you will spend everyday working on something important
  
  

If what we are saying resonates with you, please submit a resume.

Benefits

• Health Care Plan (Medical, Dental & Vision) - effective day 1
• Retirement Plan (401k)
• Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
• Voluntary Income Protection – Premiums paid by employee
• Paid Time Off (Vacation, Sick & Public Holidays)
• $500 fitness reimbursement per year
• $100 cell phone reimbursement per month
  
  

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.