Drug Safety Physician [Clin Dev]

Pharmacovigilance Physician (Drug Safety Physician)

Job Type: Full-time

Salary: $290K - $315K

Location: Remote - East Coast Preference

Company Summary: A public late-stage biotech developing breakthrough receptor antagonist therapies targeting rare, life-threatening disorders, with locations in Europe and the US (Boston).

The Opportunity: As we help expand their Clinical Develpopment team, they are looking for a Drug Safety Physician to serve as the medical safety expert across products in clinical development and post marketing settings. In this role, you will join as an experienced and driven individual contributor who reports directly into the Head of Clinical Development.

Key Responsibilities

• Serve as the medical safety expert for assigned Pharvaris products across clinical development and, as applicable, the post-marketing setting.
• Perform medical review and assessment of individual case safety reports (AEs, SAEs, SUSARs, AESIs), ensuring medical accuracy of case narratives, MedDRA coding, seriousness, causality and expectedness assessments, and raise appropriate medical queries for comprehensive review.
• Lead ongoing signal detection and management activities, including review of aggregate safety data, signal validation, prioritization, assessment and recommendation of risk-minimization actions.
• Conduct benefit-risk evaluation and contribute the medical safety perspective to safety governance and cross-functional decision-making.
• Provide medical safety input to and lead/review safety sections of Investigator Brochures, DSURs, protocols, informed consents, SmPCs/SMPs and other related safety documents to help ensure Regulatory, GCP and Legal compliance.
• Author and/or review aggregate safety reports (e.g., DSUR, PBRER/PSUR, safety sections of clinical study reports) and responses to Health Authority safety queries.
• Contribute to the development and maintenance of the safety profile, Reference Safety Information, and risk management plans (RMPs).
• Provide medical oversight of CROs and safety vendors responsible for DSPV-SAE reporting to Authorities and generation of periodic safety reports.
• Participate in and provide medical support for Regulatory inspection preparedness/audit readiness (with a focus on U.S. and EU/EMA Regulations) and DSPV or Clinical audits of CROs/vendors.
• Collaborate in related Biometrics processes (e.g., DMP reviews, IDMC/DMC Charter reviews, attend DMC meetings, eCRF and CCG reviews, SAE reconciliation, etc.).
• Provide DSPV medical advice and guidance to other functional groups, and interface to ensure harmonization of processes and data collection/content (e.g., Clinical Operations, Clinical Development, Regulatory Operations, Regulatory Affairs, Biometrics/Data Management, Quality Management, etc.).
• Attend and provide medical input at meetings (e.g., DSPV meetings with CROs/vendors, DMC meetings, safety review meetings).
• Participate in creation and revisioning of SOPs.

Qualifications:

• Medical degree (MD or equivalent) required; specialty training and/or clinical practice experience preferred.
• 7+ years of pharmacovigilance/drug safety experience in the pharmaceutical or biotech industry, including hands-on medical review of individual and aggregate safety data (Clinical Trials and Post-marketing areas).
• Demonstrated experience in signal detection and management and benefit-risk assessment.
• Knowledge of FDA, EMA, ICH and other Regulatory adverse event reporting regulations, with the ability to interpret and apply applicable regulations to resolve safety issues.
• Working knowledge of MedDRA coding conventions and safety database concepts.
• Demonstrated complex problem-solving ability and sound clinical judgement.
• Excellent written, oral communication, and presentation skills along with the ability to communicate effectively.
• Demonstrated business acumen and influencing skills.
• Highly organized, committed, results driven, problem solver.
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
• Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities.
• Self-starter, results-oriented, and proactive attitude with can-do mentality.
• Flexible/remote work model acceptable.
• Approximately 10-15% travel may be required.

If you're interested, please drop a CV and we'll be in touch if it's a good fit.