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Parabilis Medicines · 17 hours ago

Director, Drug Safety Operations

Cambridge, MA

Full-time

Onsite

Director/Executive

$200K/yr - $240K/yr

10+ years exp

Parabilis Medicines is a clinical-stage biopharmaceutical company focused on creating innovative therapies for high-impact protein targets. The Director of Drug Safety Operations will lead safety reporting activities and ensure compliance with regulatory requirements while managing relationships with CROs and consultants.

Biotechnology

H1B Sponsor Likely

Responsibilities

Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs)

Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations

Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants

Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators

Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance

Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants

Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness

Support development and maintenance of internal PV policies, SOPs, and training programs

Participate in safety signal detection activities and safety governance committees, as needed

Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events

Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations

Qualification

Pharmacovigilance experienceCRO/vendor managementGlobal regulations knowledgeDrug safety databasesLeadership skillsInterpersonal relationshipsAnalytical skillsCommunication skillsProblem-solving skills

Required

Master's degree or higher in a healthcare field

10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role

Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance oversight

Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements

Experience with oversight of drug safety databases (e.g., Oracle Argus)

Proven track record of ensuring compliance in a global PV environment

Build and maintain excellent interpersonal relationships, both within and outside the company, at all levels, and work within, lead and motivate a cross-functional matrixed team

Self-motivated; engaged, hands-on, entrepreneurial style with a sense of urgency, a bias toward action, and flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas

Analytical and problem-solving skills; risk identification and management; creative and innovative thinking

The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders

Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity

Excellent communication, negotiation, and leadership skills

Benefits

Annual target bonus

Equity

Comprehensive suite of competitive benefits designed to support our employees' overall well-being

Company

Parabilis Medicines

Parabilis Medicines™ is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer.

Founded in 2016

Cambridge, MA, US

51-200 employees

https://parabilismed.com/

H1B Sponsorship

Parabilis Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (4)

2023 (1)

2022 (2)

2020 (2)