Senior Manager, Pharmacovigilance Operations

Company introduction:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.  

We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.

We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways.

Job overview:  

The Senior Manager, Pharmacovigilance Operations will support the Pharmacovigilance Department in development, implementation, and maintenance of a safety quality system for all drug safety activities across our clinical and commercial portfolio. This role oversees pharmacovigilance activities and vendor management, ensuring compliance with global regulatory requirements while supporting COMP360's progression through late-stage clinical development and commercial readiness.

Location: Hybrid in our London office (Soho) or home-based in the United Kingdom.

Reports to: Associate Director, Pharmacovigilance Scientist.

Roles and responsibilities 
(Include but are not limited to): 

Pharmacovigilance Operations Leadership

• Take a lead role in supporting oversight of pharmacovigilance operational and case management activities for safety data processing and reporting in accordance with all applicable regulations and guidelines with little or no supervision
• Coordinate and manage serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) reporting activities for COMP360 across Phase 3 TRD, Phase 2 PTSD and anorexia nervosa studies, and once marketed products are approved
• Contribute to signal management activities and preparation of applicable periodic/aggregate safety reports including PSURs, PADERs, and DSURs
• Lead coordination of SAE reconciliation activities and contribute to safety sections of regulatory documents

Vendor Management and Quality Systems

• Oversee pharmacovigilance vendor management, performance monitoring, and quality evaluation for contracted pharmacovigilance service providers
• Create, track, and monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring to ensure compliance with service level agreements
• Ensure good understanding and implementation of pharmacovigilance agreements with partners and collaborators

Documentation and Compliance

• Support the management and maintenance of pharmacovigilance operational documents, including ongoing review, update, and alignment across processes
• Draft and update departmental SOPs, work instructions, and other work practices as assigned, ensuring alignment with GVP, ICH guidelines, and regulatory requirements
• Participate in training internal and external audiences on drug safety-related topics, as assigned
• Contribute to regulatory authority inspections and audits, including MHRA and EMA interactions

Cross-Functional Collaboration

• Collaborate with Clinical Operations, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to ensure integrated safety oversight
• Support safety data review and contribute to benefit-risk assessments for COMP360 across multiple therapeutic indications
• Partner with IT and data management teams on safety database optimization and electronic systems for pharmacovigilance activities

Candidate Profile:

• Extensive experience in the pharmaceutical/biotech industry, including at least several years of drug safety experience in clinical and post-marketing settings
• Experience with Argus safety databases, EDC systems, and electronic document management systems
• Preferred to have pharmacovigilance experience with neurological or psychiatric therapies
• Knowledge of GCP, GVP, ICH guidelines, and international regulations
• Proficiency in MedDRA and WHO Drug dictionaries
• Independently plans and organizes work and effectively manages multiple priorities and responsibilities
• Detail-oriented with good organizational and time management skills
• Strong communication and cross-functional collaboration skills
• Proficient in standard computer software (Word, Excel, PowerPoint)
• Mission-aligned with Compass's commitment to improving mental health and reducing stigma
• Demonstrates Compass' values: Compassion, Boldness, Inclusion, Rigour

Benefits & Compensation:

For an overview of our benefits package and compensation information, please visit  "Working at Compass".  

Equal opportunities: 

Reasonable accommodation

We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. 

UK applicants

We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

US applicants

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Sponsorship:

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

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