Senior Director of Pharmacovigilance
EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.
What You'll Do
You will set corporate direction for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements, for the processing and reporting of adverse events associated with drug products. You will establish the Pharmacovigilance Department direction, standards, and processes for supporting corporate pharmacovigilance operations. You will establish a safety monitoring system for drugs under development and oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems. You will supervise the activities for monitoring adverse event reports for potential drug-safety related issues and provide recommendations when potential issues are identified.
This person will lead consistent safety reviews of products across multiple stages of development and ensure that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
You will perform Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database. You will ensure that both expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate. You will liaise with Medical Monitors in Clinical Research to ensure that appropriate medical review and assessment is provided for assigned case reports. You will assist Clinical Medical Monitors in the identification, analyses, and reporting of possible trends and concerns regarding products. You will do the same for key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety. You will lead the development of signal management, safety surveillance and risk management plans for EQRx drug development programs. You will provide leadership and assist in the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.).
You will lead the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission. You will assist in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, and NDA/BLA/CTD submissions. You will facilitate and ensure communication with departments that may be involved with receiving, investigating, or reporting AEs and pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives. You will ensure awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs.
The Impact You Will Have
This is not your standard Pharmacovigilance position. We are doing things different here than how it is normally done, and this role is no exception. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.
Who You Are
- You have a Medical degree or PhD.
- You have eight years’ experience working within PV and Drug Safety in drug development pharma/biotech industry.
- You have experience with FDA and other global regulatory agencies.
- You have strong knowledge and experience with currently available drug safety database systems, electronic document management systems and QC tools. This also includes MedDRA and linked technologies.
- You have a thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
- You have experience with policy, guidance, and procedure development and maintenance.
- You have global experience and have driven new system adoption.
- You demonstrate the ability to analyze existing processes and implement effective changes as needed.
- You have Oncology and immuno-inflammatory experience.
- You can coordinate the ongoing evaluation of products technologies, services, and processes.
- You can identify opportunities to reduce costs and improve timelines.
- You are constantly reviewing publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- You monitor industry best practices, changes in global regulations and guidelines and recommend changes and upgrades to existing policies, SOPs and systems.
- You have a working knowledge of GCP/ICH guidelines and in-depth knowledge of clinical research processes, regulation and methodology.
- You can participate and work effectively on multiple cross-functional teams.
- You play well in the sandbox. You understand relationships are key and have strong interpersonal skills.
- You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.
- You can thrive in a smaller company environment and love the pace of a true startup.
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Are you bold enough?
Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.
We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities. What does EQRx stand for?
Are you ready to think differently and embrace the journey?
It’s (mutually) beneficial.
You’re curious about what sets us apart from the rest. What do you get from working at EQRx?
So, let’s start big—working at EQRx means having the opportunity to change the world.
By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:
- Working with the smartest game-changers in the industry
- Cutting down the red tape of “the way things are done”
- Seeing and feeling the daily impact of your work
- Growing as a professional and a person
- Committing to neverending social responsibility
And, yes—we also have a killer list of things that’ll help you shine as part of the team.
But to us, these are just table stakes.
- 100% Medical, Dental, and Vision coverage
- Flexible Spending Account
- Health Reimbursement Account
- Free snacks and drinks
*As EQRx grows, please note that some of these are subject to change.
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Cambridge, MA 02139