Source Job

• Author aggregate safety reports including PBRER, PSUR, DSUR, and others for submissions to health authorities.
• Coordinate with stakeholders to obtain data, plan timelines, and ensure timely delivery of reports.
• Mentor junior team members, conduct training, and maintain awareness of regulatory guidelines.

ClinChoice partners with pharmaceutical, medical device, and consumer care companies to accelerate clinical trials and ensure product safety. With a global delivery network spanning multiple countries, they provide expertise in clinical operations, biometrics, pharmacovigilance, and more.

• Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
• Oversee issue management, deviations, root-cause analysis, and CAPA activities.
• Develop and manage the global pharmacovigilance training program and procedural documentation.

Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.

• Lead global Pharmacovigilance Operations, Quality & Compliance strategy to ensure scalable, inspection-ready systems.
• Oversee case processing, vendor governance, PSMF, quality systems, audits, and regulatory inspections.
• Build and mentor a global team, collaborating cross-functionally to support portfolio growth and commercialization.

Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.

• Lead global pharmacovigilance strategy and safety governance.
• Ensure compliance with FDA, EMA, ICH, and GCP standards.
• Build and lead a high-performing pharmacovigilance organization.

Deciphera is a biopharmaceutical company focused on developing kinase inhibitors for cancer. The company fosters a culture of scientific excellence, accountability, and patient-focused decision making.

• Lead client-facing safety projects and serve as the primary point of contact for pharmacovigilance services.
• Manage project scope, timelines, and deliverables while coordinating activities across PV teams.
• Provide pharmacovigilance expertise including ICSR processing, aggregate reporting, and quality review.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses a shortlisting process to ensure fair and objective application review, and the final hiring decisions are made by the partner company.

• Develop and manage medical content for pharmaceutical, biopharma, and device clients, including SRDs, FAQs, and slide sets.
• Drive document development from material gathering through MLR review, using tools like Veeva PromoMats.
• Collaborate with global teams to ensure timely, high-quality, compliant deliverables that meet client needs.

EVERSANA provides next-generation commercialization services to the life sciences industry. With over 7,000 employees globally, the company serves more than 650 clients and is certified as a Great Place to Work, fostering an inclusive culture.

• Provide support to other activities undertaken by the project team on behalf of the client and the company.
• Create and maintain project-specific KPIs for contracted ICSR activities, proposing process changes to the ICSR Operational Lead.
• Manage ICSR deviations, review trackers and timesheet data for accuracy, and operate as the assigned team SME.

PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. The company operates across Europe, North America, South America, Asia, and Australia in a culture built on kindness, flexibility, growth, and belonging.

• Lead quality assurance activities to support patient safety and pharmacovigilance compliance across global operations.
• Plan, conduct, and manage pharmacovigilance audits, CAPA programs, and regulatory inspection readiness activities.
• Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to maintain robust quality systems.

This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.

• Develop high-quality clinical and regulatory documents supporting global submissions
• Partner with cross-functional teams to transform complex scientific data into clear narratives
• Ensure compliance with regulatory requirements while managing document timelines

Acadia Pharmaceuticals is a biopharmaceutical company developing innovative therapies to address unmet medical needs in neuroscience. With a collaborative and patient-focused culture, the company is committed to advancing treatments that improve lives.

• Lead the preparation of complex clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
• Collaborate with clinical development teams and stakeholders to produce accurate, compliant, and scientifically robust documentation.
• Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.

Our partner is a specialized medical writing team supporting the development of high-quality regulatory documentation for the global pharmaceutical industry. It offers a collaborative, remote environment focused on quality, precision, and scientific communication.

• Lead strategic development and continuous evolution of the Medical Information function to support COMP360 and pipeline assets.
• Oversee development of compliant medical information response documents and collaborate cross-functionally to ensure alignment.
• Establish scalable capabilities, metrics, and innovation in technology and service delivery to enhance operational excellence.

Compass Pathways plc is a biotechnology company dedicated to developing new treatment options in mental health care, with a focus on COMP360 psilocybin for treatment-resistant depression and PTSD. The company is headquartered in London, UK, with a US office in New Jersey, and leads one of the largest clinical programs in psychedelic treatments.

• Lead development of complex medical writing and publication deliverables for clinical studies.
• Define document strategies and coordinate writing activities across multidisciplinary teams.
• Mentor less experienced writers and enhance processes to ensure high-quality outputs.

A global life sciences and healthcare company offering integrated services across the industry. It fosters an inclusive, collaborative culture focused on employee growth, professional development, and delivery of important therapies.

• Set the strategic direction for scientific content across client accounts, ensuring alignment with client objectives and medical priorities.
• Provide senior-level oversight and ensure quality, accuracy, and consistency of all deliverables.
• Lead cross-functional teams, mentor junior staff, and contribute to business development through proposals and pitches.

Precision Medicine Group is a medical communications company that provides scientific content and strategy for pharmaceutical and biotech clients. They are known for award-winning work, strong client partnerships, and a commitment to professional development.