Secura Bio was established in 2019 with a singular mission: to close the gap between innovative oncology therapies and the patients who need them most. Our high-touch approach is informed by our decades of experience shaping the impact of oncology’s largest clinical and market opportunities. We know that true impact comes from personalization and an unwavering commitment to serve patients and expand the possibilities of life-prolonging oncology medicines.

About the Role

We are seeking a talented and motivated Senior Manager of Pharmacovigilance (PV) to drive safety surveillance activities and aggregate reporting initiatives at Secura Bio (SBI). This position plays a critical role in ensuring patient safety through comprehensive signal detection, risk assessment, and regulatory compliance across our product portfolio.

The successful candidate will lead cross-functional safety surveillance efforts, managing the end - to-end process from data collection and analysis to regulatory submission. They will collaborate closely with internal teams, external vendors, and regulatory authorities to deliver high-quality safety reports including PSURs, DSURs, and risk management plans. This role combines deep pharmacovigilance expertise with strong project management skills to oversee vendor relationships, coordinate global safety review committees, and drive continuous process improvements.

As a key member of our Drug Safety team, the successful candidate will support inspection readiness, contribute to signal detection methodologies, and help maintain our Core Company Safety Information (CCSI). This position offers the opportunity to make a meaningful impact on patient safety while working in a collaborative, science-driven environment focused on advancing innovative therapies.

Employment Type

Full Time

Reports To

Executive Director Global Drug Safety

Key Responsibilities

• Collaborate with SBI data suppliers and/or vendors on signal detection process including data collection, analysis and reporting as well as coordinate signal detection meetings and document appropriately.
• Supervise and document decisions on the signal management system including signal detection,
• validation, assessment and potential impact on company core safety information (CCSI).
• In collaboration with the Head of Global Drug Safety, manage the company’s global safety review committee including interaction with the SVP of Clinical and Medical Affairs, additional internal stakeholders, and external data suppliers.
• Responsible for taking meeting minutes during the company’s GSCR meeting and tracking key decisions.
• Support the Head of Global Drug Safety in the preparation, review, approval, and version control of CCSI or potential safety variations in coordination with key stakeholders, recording all supporting documentation in the CCSI preparation.
• Provide scientific and safety support for the preparation, quality control and compliance of Benefit-Risk and/or aggregate safety reports including PSUR, DSUR, risk management plan, assessment reports, risk evaluation mitigation strategy reports and regulatory responses, and provide assistance with project plans for timely execution. Coordinate business reviews of all contract proposals and support vendor analysis and presentation to SBI senior leadership.
• Develop and align with PV project management timelines for the preparation and submission of all aggregate safety reports or REMS reports for regulatory submissions.
• Co-lead PV vendor oversight plan for assigned projects and monitor vendors KPIs, compliance metrics, invoice management versus budget and quality standards for the deliverables.
• Collaborate with the Head of Global Drug Safety and Regulatory members to develop submission schedule for all aggregate safety reports, REMS documents and other regulatory documents for Regulatory Submission to ensure effective project management.
• Support PV inspection and audits by health authorities and prepare response documents to
• auditors or inspectors when needed.
• Responsible for up-to-date continuous process improvement/quality documentation for safety surveillance, and aggregate reporting at SBI.
• Build and maintain strong, positive client relationships, ensuring client satisfaction and contract renewals. Explore opportunities for new business with existing clients.

Required Qualifications

• Bachelor’s degree in life sciences or related fields. Advance degree in life sciences or MBA or certification in project management is preferred.
• At least 10 years of experience in life sciences related industry or a Clinical Research
• Organization.
• Over 5 years’ experience in drug development or proven data analysis skill in development
• or product safety.
• Formal medical writing certification or direct regulatory or safety report preparation is a plus.
• Ability to manage multiple projects and prioritize tasks effectively.
• Strong decision-making, negotiating, and problem-resolution abilities.
• Strategic business acumen, financial analysis, tactical planning, and budgeting expertise.
• Proven ability to establish and maintain effective working relationships with colleagues, managers, and clients.
• Excellent communication and collaboration skills within a matrix organization to achieve results.