Senior Pharmacovigilance Physician: Safety Signals Lead

MMS; Boston (MA); In loco; USD 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

MMS is a data-focused clinical research organization seeking a Senior Pharmacovigilance Physician to lead complex medical-review assignments and provide expert safety judgment. You will lead discussions with clients and serve as a medical SME for reviewers, with independence and expertise guiding safety deliverables.

The role requires MD/DO with 5+ years in pharmacovigilance, strong regulatory knowledge, and proficiency in MedDRA/WHO Drug dictionary.

Competenze

• MD or DO degree required; board certification preferred.
• Minimum of 5 years’ experience in pharmacovigilance, safety signal detection, and aggregate report review/authoring.
• Excellent communication and problem-solving skills.
• Familiarity with ISO 9001 and ISO 27001 standards; 21 CFR Part 11, FDA, and GCP.
• Proficiency with MedDRA and WHO Drug dictionary; safety deliverables.
• Experience reviewing ICSRs from clinical trials, literature, and other sources.

Mansioni

• Lead end-to-end signal management and safety surveillance activities.
• Oversee signal detection and regulatory updates; mentor others.
• Manage client meetings, feedback and SRMs.
• Review ICSRs from trials and literature; ensure accurate medical information.
• Prepare safety deliverables (DSURs, PADER, PBRER) and related communications.

Conoscenze

Signal management

Safety surveillance

MedDRA/WHO Drug dictionary

Regulatory updates

Clinical data coding

DSURs/PADER/PBRER

Safety reporting

Medical review

Client meetings / SRMs

Pharmacovigilance

Formazione

MD/DO degree

Strumenti

MS Office

Descrizione del lavoro

MMS is a data-focused clinical research organization seeking a Senior Pharmacovigilance Physician to lead complex medical-review assignments and provide expert safety judgment. You will lead discussions with clients and serve as a medical SME for reviewers, with independence and expertise guiding safety deliverables.

The role requires MD/DO with 5+ years in pharmacovigilance, strong regulatory knowledge, and proficiency in MedDRA/WHO Drug dictionary.