Director/Senior Director, Safety-PV Operations Lead (EU)

About Prilenia

Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, Safety-PV Operations Lead in Europe, to support programs in both Huntington’s Disease and ALS.

We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is conducting global Phase 3 clinical trials in both HD and ALS.

Pridopidine has the potential to be a pivotal treatment to address HD and ALS disease progression. Prilenia believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist also gives it potential in numerous other neurodegenerative and neurodevelopmental conditions.

To learn more about our story and company culture, visit us at https://Prilenia.com 

About the role

We are seeking an experienced safety professional to join our team as Safety-PV Operations Lead (Director/Senior Director).

The Safety-PV Operations Lead is a key position responsible for developing strategy and providing operational support for Prilenia's PV model. This role is critical in ensuring a lean, agile, and cost-efficient organization that delivers excellence in safety operations.

This position will take ownership of Prilenia’s safety operations and manage safety vendors and CROs. This position will closely work together with the Head Global Medical Safety. The ideal candidate will have experience in a similar position in safety and pharmacovigilance, in-depth knowledge of global safety requirements, and experience with working in both small and larger biotech environments. The position will report to the Head of Safety.

Prilenia has offices in the U.S., Israel and The Netherlands. Prilenia is a highly virtual and flexible organization and encourages team members to work in the ways that make them most effective, with a focus on our common goals and drive to move things forward.

Roles and Responsibilities:

· Provide strategic direction and manage global safety operations for Prilenia

· Responsible for developing and maintaining safety operational documents with partners (such as Joint Operating Guides, Safety Management Plans (SMP), Safety Data Exchange Agreements)

· Coordinate generation of core safety documents (such as DSUR, RSI in IBs, CCSI, and RMP/REMS) in consultation with RA

· Responsible for arranging high quality safety outputs in consultation with Biostatistics, QA and external vendors

· Support ongoing safety monitoring (signal management) and periodic reporting

· Be principal point of contact and proactively manage Prilenia´s safety vendors. Organize work orders, budgets and required administrative tasks.

· Responsible for ensuring that safety KPIs are met by vendors and that compliance with SMPs is maintained, and that risk mitigation measures are implemented as required

· Responsible for safety procedures (governance model, SOPs), appropriate for state of product development and in preparation for future commercialization; work with QA to ensure that training is appropriately rolled out and documented

· Work closely and seamlessly with Head Global Medical Safety

· Represent Safety operations at governance and decision forums

· Partner with key internal departments such as RA, PV QA, medical writing to maintain regulatory/safety compliance. Align expectations with regards to safety requirements

· Represent Prilenia towards development/commericalisation partner in regards to Safety operations

· Participate in clinical trial teams and EAPs

Qualifications and Skills:

· Advanced degree (PhD, PharmD, MSc) in a life-science or medical subject

· At least 5 years of experience in a similar position in pharmacovigilance with significant experience in both small biotech and larger pharmaceutical companies.

· Experience in late-stage development and initial commercialization and with compassionate use/expanded access.

· In-depth knowledge of global safety requirements incl. GVP and CFR 11

· Experience with safety systems, including ARGUS, VEEVA, MedDRA

· Experience in managing external partners and vendors

· Experience of pre- and post-marketing safety/PV requirements

· Experience in creating and maintaining CCSI & initial RMP/REMS

· Experience of dealing with regulators, such as FDA/Health Canada/EMA PRAC, on risk management plans and risk minimization activities

· Excellent communication skills, both written and verbal

· Hands-on approach to problem solving with a willingness to take on responsibility for getting documents in place

· Ability to work independently and collaboratively in a team environment