Director, Global Medical Safety Lead

Planet Pharma; Genf; Hybrid; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Planet Pharma seeks a Global Medical Safety Lead to oversee strategic pharmacovigilance across products and functions in a hybrid role. You will drive safety signal detection, risk assessment and regulatory submissions input, coordinating with Clinical Development, Regulatory Affairs and Medical Affairs.

You will lead aggregate safety reporting and ICSR oversight, ensuring high-quality safety documentation and timely SUSAR responses.

Qualifikationen

• MD/MBBS or equivalent medical degree required.
• Significant pharmacovigilance/Drug Safety experience from pharma/biotech.
• Expertise in safety signal management, risk assessment, and aggregate reporting.

Aufgaben

• Act as the medical safety lead for assigned products, providing strategic PV across clinical, regulatory and cross-functional teams.
• Lead safety signal detection, evaluation and risk assessment activities.
• Chair or contribute to cross-functional safety review meetings and drive evidence-based decision making.
• Support safety governance processes and lifecycle safety oversight.
• Provide medical safety input into global regulatory submissions and ensure timely, high-quality documentation.
• Author and review safety sections in study protocols, investigator brochures, CSRs and IC documents.
• Lead preparation and review of PSURs and DSURs to ensure regulatory compliance.
• Oversee evaluation of ICSRs and guidance on SUSARs and urgent safety issues.
• Present safety data to governance committees and authorities as required.
• Support regulatory inspections, audits and PV compliance.
• Contribute to development of PV procedures, training and safety agreements.

Kenntnisse

Pharmacovigilance

Safety signal management

Aggregate safety reporting

Regulatory submissions input

Cross-functional collaboration

Ausbildung

MD/MBBS or equivalent medical degree

Jobbeschreibung

Planet Pharma are currently partnered with an exciting global biotech and we are actively seeking an experienced Global Medical Safety Lead to join the business on a permanent basis. This is a hybrid role.

Key Responsibilities:

• Act as the medical safety lead for assigned products, providing strategic pharmacovigilance and benefit-risk expertise across clinical, regulatory and cross-functional teams.
• Lead safety signal detection, evaluation and risk assessment activities, ensuring emerging safety data is reviewed and interpreted effectively.
• Chair or contribute to cross-functional safety review meetings and drive evidence-based decision making regarding product safety profiles.
• Support the development and execution of safety governance processes, helping to maintain robust oversight of product safety throughout the lifecycle.
• Provide medical safety input into global regulatory submissions, ensuring high-quality safety documentation is delivered on time.
• Author and review safety sections within key clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports and informed consent documents.
• Lead the preparation and review of aggregate safety reports such as PSURs and DSURs, ensuring scientific accuracy, consistency and regulatory compliance.
• Oversee the medical evaluation of individual case safety reports (ICSRs) and provide guidance on expedited reporting requirements, including SUSARs and urgent safety issues.
• Present safety data to governance committees, Data Safety Monitoring Boards and health authorities as required.
• Support regulatory inspections, audits and pharmacovigilance compliance activities.
• Contribute to the development of pharmacovigilance procedures, training initiatives and safety agreements with internal and external partners.
• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs and other stakeholders to ensure patient safety remains central to decision making.

Key Requirements:

• MD, MBBS or equivalent medical degree.
• Significant pharmaceutical or biotechnology industry experience, including substantial experience within Pharmacovigilance/Drug Safety.
• Demonstrated expertise in safety signal management, benefit-risk assessment and aggregate safety reporting.

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com