Manager/Senior Manager, Drug Safety Operations

Role Summary

We are seeking a skilled and proactive Manager/Sr. Manager of Drug Safety Operations to support and enhance our PV infrastructure. Reporting to the Sr. Director, Drug Safety Operations, this role oversees outsourced safety operations and internal safety activities, ensuring vendor compliance, timely case processing, and adherence to regulatory requirements across clinical and post-marketing programs. The role addresses complex project management challenges, maintains safety reporting compliance, and contributes to inspection readiness and scalable PV processes. Ideal candidates will have hands-on experience in vendor oversight, PV systems, and operational compliance, with the ability to collaborate cross-functionally in a fast-paced biotech/pharmaceutical environment. Remote role based in the US, with less than 10% travel to our Boston, MA headquarters.

Responsibilities

• Oversight of key functions delegated to Safety Vendor including all case workflow steps (triaged, processed, communicated with Sponsor and submitted/distributed) in a timely manner, as defined in the Safety Management Plan (SMP).
• Ensure the safety vendor submits SUSARs in a timely manner to Regulatory Authorities (RAs), Ethics Committees, and IRBs, in accordance with global and local regulatory requirements.
• Liaise with the safety vendor and Centessa Quality, as required, relating to quality issues or process deviations identified.
• Collaborate with internal or external Medical Reviewers, as applicable, relating to case Medical Review/Sponsor Review feedback and workflow processes.
• Participate in study team meetings for assigned compounds or studies to facilitate effective communication between the clinical team, safety vendor, and other key functions such as data management (e.g., reconciliation) and medical writing/clinical science (e.g., safety-related protocol sections and reporting processes).
• Collaborate with safety vendor for timely completion and submission of aggregate reports review (DSUR, 6MLLs, etc. and PBRERS, PADERS).
• Other vendor oversight activities, as requested, including maintenance of SMP, safety communication distribution lists, Contract / Change Orders for new studies; oversight of compliance metrics; and site start up safety training.
• Develop templates, trackers, and other tools to aid in oversight and/or standardization of PV processes (as applicable)
• Collaborate with Quality Assurance to assure compliance, alignment, and a state of continual audit readiness.

Qualifications

• Completed degree in Life Sciences, Pharmacy, Nursing, or a related field required.
• Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, or with a drug safety vendor, including at least 3 years specifically in drug safety operations
• Prior experience in safety vendor oversight, audit/inspection readiness, and supporting pre- and post-marketing safety activities.
• Working understanding of global pharmacovigilance (PV) regulations as pertains to clinical development, e.g. FDA, EMA/EU CTR, PMDA, GCP, and ICH guidelines.
• Working knowledge of PV databases (e.g., Argus, ArisGlobal, Vault Safety); experience with MedDRA coding and clinical database interface for AE CRFs preferred.
• Demonstrated ability to oversee drug safety operational activities related to aggregate safety reports, signal detection, safety surveillance, and literature review processes.
• Familiarity with regulatory submission processes (e.g., NDA/BLA/MAA) and late-stage clinical development is preferred; direct experience supporting these activities is a plus.
• Self-starter with strong decision-making skills who thrives in a fast-paced, dynamic environment, while remaining open to collaboration and guidance.
• Strong organizational, project management, and problem-solving abilities.
• Effective communicator with well-developed presentation and interpersonal skills.
• Strong attention to detail and accountability for deliverables.