Merida Biosciences · 22 hours ago
Director/Sr. Director, Drug Safety & Pharmacovigilance
Cambridge, MA
Full-time
Onsite
Director/Executive
$210K/yr - $243K/yr
8+ years expMerida Biosciences is pioneering precision medicines for antibody-driven diseases. The Director/Sr. Director, Drug Safety and Pharmacovigilance is responsible for managing safety surveillance, reporting, and risk management strategies for clinical stage development assets, serving as a scientific safety expert while overseeing outsourced pharmacovigilance operations.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Lead ongoing safety review and signal detection, evaluation, and management activities for development assets
Supports build out of safety analytics and reporting infrastructure, such as developing standard procedures and templates
Author, review, and approve aggregate safety reports, including DSURs, PBRERs/PSURs, and ad hoc safety assessments
Serve as the lead/coordinator and key contributor for internal Safety Review Committees or other safety governance bodies at the trial and asset level
Provide expert safety science input for key regulatory and clinical documents, such as protocols, informed consents, Investigator's Brochures, Clinical Study Reports, and integrated summaries of safety
Strategizing and drafting of responses to regulatory inquiries on safety issues inclusive of defining MedDRA search strategy
Supports activities related to new drug applications and other regulatory filings
Represent drug safety at regulatory inspections i.e. MHRA, FDA, EMA, etc
Serve as the primary point of contact and relationship manager for outsourced PV CRO vendor(s), ensuring a collaborative and effective partnership
Oversee CRO vendor budget, review invoices, and participate in contract renewals and negotiations
Establish, monitor, and report on Key Performance Indicators (KPIs) and quality metrics to ensure the CRO's adherence to timelines, regulatory requirements, and quality standards
Provide oversight of the CRO's case processing (ICSR) and regulatory reporting activities, ensuring all safety data is handled with the highest level of accuracy and compliance
Supports safety database and clinical database adjudications
May lead gap analysis to ensure alignment with changes in global regulations
Qualification
Required
Advanced degree in a biologic/medical/clinical/nursing field required (PharmD, Nurse Practitioner, Ph.D.)
At least 8 + years' experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry. Experience working in a start-up environment is desirable
Deep knowledge and understanding of US and EU safety regulations pre-and post-marketing
Demonstrated expertise in signal detection, risk management, and authoring aggregate safety reports for both investigational and marketed products
Strong experience with clinical development including risk/benefit analysis and safety assessment
Experience directly managing CROs, PV service providers, or other outsourced vendors
Experience successfully leading or playing a key role in regulatory authority interactions and inspections
Strong analytical, problem-solving and scientific writing and communication skills
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Benefits
Comprehensive benefits package designed to support you both personally and professionally
Company
Merida Biosciences
Merida Biosciences is a biotech company focused on developing precision treatments, particularly for autoimmune diseases.
11-50 employees
H1B Sponsorship
Merida Biosciences 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 (3)
Funding
Current Stage
Early StageTotal Funding
$121MKey Investors
Third Rock Ventures
2025-04-08Series A· $121M
2022-01-01Seed
Company data provided by crunchbase