Associate Director, Pharmacovigilance Operations, Remote US

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. Our business requirements are to work to accommodate Eastern Time Zone. To work in synergy, it is preferred that our applicants can work Eastern Time Zone to accommodate team and client meetings.

Overview

Reporting into the Senior Director, Drug Safety and Pharmacovigilance (PV), the Associate Director, PV Operations supports the PV operational-related activities to ensure compliance with applicable global regulations for adverse event reporting and safety management of POINT Biopharma products in development, from early phase trials to eventual marketing approval.

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.
• Provide PV expertise and leadership to the cross functional teams on all matters related to adverse event collection and reporting

• Support Drug Safety and PV in the maintenance of a highly effective safety organization in full compliance with worldwide regulations.

Accountabilities

• As primary point of contact for the PV vendor, provide oversight of all activities related to case processing and related reporting
• Liaise with the cross functional team to gather and provide input for appropriate sections of clinical documents (e.g., protocols and amendments, ICFs, IBs, RSIs, CSRs).
• Contribute to the development and revision of PV Standard Operating Procedures and Policies
• Contribute to activities in the monitoring of compliance with regulations
• Manage PV related agreements such as Safety Management Plans and Safety Data Exchange Agreements
• 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.
• 7+ years of experience in a Drug Safety/Pharmacovigilance role in the pharmaceutical/biotechnology industry, including global clinical trials and post-marketing, or equivalent experience.
• Previous managerial role in Drug Safety preferred
• Knowledge of FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance and application to safety data collection and reporting within PV
• Proficiency in English both written and spoken and excellent written and verbal communication skills with the ability to interact across multiple functions
• Experience using ARISg or Argus safety database application is required

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

• Eligible for annual incentive bonus plan and stock options
• Health Care Plan (Medical, Dental & Vision) – effective day 1
• Retirement Plan (matching 401k)