Senior Aggregate Safety Reports Lead

Lancesoft; Cambridge (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Lancesoft seeks an experienced pharmacovigilance professional to oversee the authoring of aggregate safety reports (PSUR, DSUR, line listings) in close collaboration with the cross-functional lead and Safety Physician. You will manage all line listings for the PV Science group, including generation through submission.

You will work with affiliate management and regulatory teams to develop SMPs/ESRPs and address SMP/ESRP issues, while proactively identifying gaps in reporting processes and

Qualifications

• Degree in a medical or healthcare related discipline required.
• 3–5 years in pharma industry with PV/safety experience.
• Ability to work in a matrix environment and across geographies.
• Knowledge of global PV regulatory requirements.
• Experience with safety reporting and risk management.

Responsibilities

• Lead authoring for aggregate safety reports (PSUR, DSUR, line listings) in collaboration with cross-functional teams.
• Oversee management of all line listings and submissions for the PV Science group.
• Develop and edit SMPs/ESRPs with regulatory input and affiliate coordination.
• Identify gaps in aggregate reporting processes and drive changes.

Skills

Pharmacovigilance

Regulatory knowledge

Cross-functional collaboration

Analytical writing

Project management

Education

MSN/ RN/ PharmD/ PA/ MD

Tools

Argus

ARiSG Safety Databases

Empirica

Spotfire

Job description

Lancesoft seeks an experienced pharmacovigilance professional to oversee the authoring of aggregate safety reports (PSUR, DSUR, line listings) in close collaboration with the cross-functional lead and Safety Physician. You will manage all line listings for the PV Science group, including generation through submission.

You will work with affiliate management and regulatory teams to develop SMPs/ESRPs and address SMP/ESRP issues, while proactively identifying gaps in reporting processes and