Talent Orchard is a boutique talent acquisition consulting firm, we have been retained by a growing Biotechnology company to assist in managing their recruiting activities as an exclusive retained partner. Our client, The Medicines Company, wishes to add a Director level Surveillance Scientist to its highly impactful team focused on global pharmacovigilance and safety risk management. This critical role will specifically support the pre and post marketing drug safety activities for the Cardiovascular therapeutic pathway, but will be expected to have the agility to support colleagues in other therapeutic pathways and contribute to the development of policies and procedures for a growing global pharmacovigilance department. The Director, Surveillance Scientist role is a unique, diverse and challenging position, allowing you the opportunity to impact directly all aspects of safety handling and signal management for products in development or on the market.

Primary Responsibilities:

• Support the Global Safety Officer in monitoring the safety profile of products in assigned therapeutic area, including signal detection, evaluation of safety information, and management of signal evaluation activities and documentation
• Manage the preparation of aggregate safety reports (PBRER, PADER, DSUR), Risk Management Plans, Development RMPs, relevant sections of regulatory documents and health authority responses
• Provide scientific and PV regulatory input into safety documents and relevant sections of regulatory documents such as clinical study reports, protocols, safety analyses, expert statements, submission dossiers, and health authority responses
• Support operational and process improvement activities within GPV, e.g. data handling conventions, signal detection and management, safety analyses, safety data exchange agreements, safety data collection in clinical trials/postmarketing studies.
• Support business development activities, regulatory authority inspections, training, product recalls, and projects, as needed.
• Support clinical development team including core members based in California.
• PV oversight for both marketed products and those in development.

• Join a small but highly influential team focused on ensuring the safety of all products both in development and on the market for The Medicines Company?
• Be the “go to” person from Global Pharmacovigilance for colleagues in clinical, regulatory, quality, and other departments within your therapeutic pathway?
• Manage the preparation of aggregate safety reports and regulatory authority responses on safety issues?
• Partner with the Global Safety Officer in monitoring the safety profile of products including signal detection, evaluation of safety information, and management of signal evaluation activities?
• Provide your insights and experience to assist the Head of Global Pharmacovigilance in building a model organization, where colleagues can support each other and gain a breadth of experience unlike any other comparable-sized or larger pharmaceutical firm?

• Bring your deep experience in Safety and Pharmacovigilance to a receptive team, where your skills and opinions will count and where you will be engaged in every aspect of the drug development process?
• Jump in and get up to speed fast with responsibility for 3 or 4 products of major significance for the firm, including learning how PV and Safety Operations work within a fast paced multi-product environment.
• Work on multiple products within the Infectious Disease therapeutic pathway ranging from significant marketed products to highly innovative early stage solutions, all with a focus on critical clinical care?
• Work within a fast paced and every changing environment where shifting priorities require intellectual agility and superior organizational skills.
• Contribute to monitoring of worldwide safety information for products within your portfolio?
• Be a member of a talented and close-knit PV team who play a significant role working with clinical teams.
• Act like an owner as it relates to all activities associated with product safety and pharmacovigilance?
• Be an ambassador for Global Safety in all interactions within the company and externally, including interaction with alliance partners and regulators?

   

• Bachelor’s Degree in a healthcare discipline, such as Nursing or Pharmacy or equivalent with an advanced degree preferred.
• Prior practical clinical experience is a requirement for this role, for example working as a nurse or Pharmacist within a clinical environment, preferably a hospital setting..
• Demonstrated experience in pharmacovigilance, operations and including knowledge of US, ICH and EU regulations impacting Pharmacovigilance.
• Must have PV experience with both marketed products and clinical trials, preferably including critical care and/or infectious disease.
• Demonstrated ability to organize, prioritize and manage safety compliance deliverables with a focus on patient safety and regulatory compliance.
• Clear prior examples of working to review clinical protocols and partnering with Safety Officers.
• A good understanding of safety handling in clinical trials and/or post marketing surveillance.
• Demonstrated examples of agility and adaptability to changing priorities while maintaining focus on key deliverables.
• The ability to provide examples of good organizational skills while working within a fast paced and agile environment with strict deadlines.
• Global and cross functional team experience.
• At least 5 years of experience in global pharmacovigilance within a pharmaceutical or biotechnology firm.
• Prior experience working with drug safety databases, as well as planning and preparing safety regulatory reports.