Associate Directors, Deputy Local Patient Safety Officer

Job Title: Associate Directors, Deputy Local Patient Safety Officer

Job Location: EMD Serono Research and Development Institute Inc., 200 Pier 4 Boulevard, Suite 300, Boston, MA 02210

Responsibilities:

The Associate Directors, Deputy Local Patient Safety Officer provide safety expertise to clinical development programs and performs pharmacovigilance with rapid identification and analysis of safety signals to define emerging drug safety profiles of products and drive patient risk management. Responsibilities include:

1. Ensuring pharmacovigilance benefit-risk management of all products on the market and under development in the US;
2. Supporting the development, as well as manage and execute the risk evaluation and mitigation (REMS) strategy for new programs, ensuring proper oversight and documentation of the REMS program activities;
3. Leading and executing PV operational tasks in the US region such as developing and maintaining standard operating procedures (SOPs), implementing new processes and ensuring quality and compliance to local FDA regulations;
4. Managing local affiliate PV department and staff management;
5. Serving as interim Global Patient Safety representative for the local affiliate in LPSO’s absence;
6. Maintaining and ensuring quality and compliance of the Local PV System;
7. Representing Global Patient Safety as an affiliate representative on local cross-functional teams and activities;
8. Preparing, managing, following-up, and actively participating as a subject matter expert in local PV related audits and Health Authority inspections;
9. Ensuring compliance and overseeing that all other applicable core PV activities or processes in the local affiliate are completed in a timely manner with high quality; AND
10. Contributing to US Product launch activities and new product registrations.

Requirements: Employer requires a Master’s degree in Pharmacy, Pharmaceutical Sciences, Medicine, or a closely related field and four (4) years of work experience in any occupation performing pharmacovigilance (PV) activities within the pharmaceutical, medical device, or biotech industry. Employer also requires the following:

1. Demonstrated knowledge of local PV regulations and requirements, including FDA REMS regulations and guidelines, and awareness of applicable international PV regulatory requirements gained through at least four (4) years of work experience;
2. Demonstrated ability interacting with stakeholders both locally and globally gained through at least four (4) years of work experience;
3. Demonstrated ability prioritizing tasks, leading strategic projects, and rapidly adapting to changing priorities gained through at least three (3) years of work experience;
4. Demonstrated experience in Product Launch Activities gained through at least three (3) years of work experience;
5. Demonstrated experience participating in health authority inspections and audits gained through at least three (3) years of work experience; and
6. Demonstrated knowledge of drug development and life-cycle management performed across different business functions gained through at least three (3) years of work experience.

All years of experience may be gained concurrently.

Telecommuting is an option as long as the employee is based in the Boston, MA region as the employee must conduct regular visits to company offices in the Boston, MA region. 15% domestic travel and 5% international travel required per year.

This position is eligible for the EMD Serono Research and Development Institute, Inc.’s Employee Referral Program.

Applicants can send resumes to EMD Serono Research and Development Institute, Inc., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req#279735) or apply online https://careers.emdgroup.com