Job Description
Description:
Director, Drug Safety & Pharmacovigilance At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.
Reporting directly to the CMO of Merida, the Director, Drug Safety and Pharmacovigilance is a leadership role responsible for managing the safety surveillance, reporting, and risk management strategies for our clinical stage development assets. This individual will serve as a scientific safety expert, while also providing strategic oversight of outsourced pharmacovigilance operations and reporting activities conducted by CRO vendor(s). This role requires a deep understanding of safety science combined with proven experience in vendor management and operational excellence.
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 adjudication
- May lead gap analysis to ensure alignment with changes in global regulations
Requirements - 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
Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Director level we target between $210,000-$243,000. The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally.
Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
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