Manager/Senior Manager, Drug Safety Operations

Role Summary

Manager/Senior Manager, Drug Safety Operations responsible for day-to-day oversight of outsourced safety operations and internal safety team activities, ensuring vendor compliance, timely case processing, and regulatory adherence across clinical and post-marketing programs. Leads complex project management, maintains safety reporting compliance, and contributes to inspection readiness and scalable PV processes.

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, Ethics Committees, and IRBs, in accordance with global and local regulatory requirements.
• Liaise with the safety vendor and Centessa Quality regarding quality issues or process deviations identified.
• Collaborate with internal or external Medical Reviewers relating to case Medical Review/Sponsor Review feedback and workflow processes.
• Participate in study team meetings to facilitate communication between the clinical team, safety vendor, and other key functions such as data management and medical writing/clinical science.
• Collaborate with safety vendor for timely completion and submission of aggregate reports review (DSUR, 6MLLs, etc. and PBRERS, PADERS).
• Support other vendor oversight activities, 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 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.

Education

• Not specified beyond degree in Life Sciences, Pharmacy, Nursing, or related field.

Additional Requirements

• Work Location: Remote role based in the US, with less than 10% travel to headquarters in Boston, MA.