Executive Director, GPS Head of Case Evaluation and Reporting
We are seeking to fill a senior-level Pharmacovigilance (PV) operations position, reporting to the Head of Global Patient Safety (GPS). The primary focus of this role is to be accountable for procedures and policies that enable the highest standards of PV operational support for Phase I-IV clinical studies. This person will also be responsible for the management of individual case safety report (ICSR) processing, evaluation and regulatory reporting in clinical trials and post-marketing.
As Executive Director, GPS Head of Case Evaluation and Reporting, a typical day might include:
- Leading and managing the Case Evaluation and Reporting Management (CERM) team and PV Planning (PVP) team in accordance with corporate management standards and policies for performance management
- Providing direction and guidance to CERM and PVP to ensure high quality and compliance with global regulations
- Ensuring timely submission of expedited safety reports and other external submissions through effective processes, systems, and internal staff and vendor management
- Maintaining oversight of study specific set up activities such as but not limited to case processing conventions, queries, investigator site training, PV ops support for investigator-initiated studies (IIRs), market research programs (MRPs) and patient support programs (PSPs)
- Providing oversight of systems conventions/guidelines and MedDRA updates in collaboration with the relevant safety vendor
This role might be for you if:
- You have excellent communication and leadership skills
- You have an outstanding ability and skills to lead through ambiguity and work effectively with senior management and cross functional partners
- You are very comfortable working within a highly matrixed environment and influencing across functional areas outside of direct line management
To be considered for this position you must have a BS in health sciences. PhD, PharmD or MD is a plus but not required. An MBA is also considered a plus. You should have at least 10 years of pharmacovigilance experience, particularly in case management, quality standards and regulatory requirements for patient safety. Clinical experience is highly preferred but not required. Experience with case processing tools, safety databases and processes. At least eight years of people management experience and/or manager of third-party service providers also required.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.