Senior Director, Medical Monitoring (MM) and Pharmacovigilance (PV)

Kelly Science, Engineering, Technology & Telecom; United States; Remote; USD 285,000 - 330,000; Full time

Job summary

A leading company in the pharmaceutical industry is searching for a Senior Director of Medical Monitoring and Pharmacovigilance. This pivotal role involves leading medical activities, ensuring regulatory compliance, and managing safety surveillance, essential for driving clinical development in CNS drug therapy. The ideal candidate will hold an MD or DO and have extensive experience in the pharmaceutical sector.

Qualifications

• US board-certified physician (preference in psychiatry) with 10+ years of relevant experience.
• Experience in NDA and IND submissions preferred.
• Strong knowledge of regulatory requirements (GCP, ICH guidelines).

Responsibilities

• Lead all medical activities including interaction with clinical sites and initial safety review.
• Oversee medical monitoring plans and ensure compliance with regulations.
• Manage overall clinical risk and safety surveillance of investigational products.

Skills

Leadership

Communication

Regulatory Compliance

Analytical Thinking

Education

MD or DO with relevant post-graduate clinical training

Job description

Senior Director, Medical Monitoring (MM) and Pharmacovigilance (PV)

Senior Director, Medical Monitoring (MM) and Pharmacovigilance (PV)

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Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$285,000.00/yr - $330,000.00/yr

Kelly Science & Clinical is seeking a Senior Medical Director for a fulltime, Direct Hire role with a pharmaceutical client based in the San Fran Bay area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Overview:

The Senior Director, Medical Monitoring (MM) and Pharmacovigilance (PV) will serve as a thought leader, with a high level of experience as a medical professional with a strong ability and broad knowledge of MM, global drug safety, and post-marketing safety surveillance. This role will lead all medical activities including, but not be limited to, interaction with clinical research sites and CROs, MM of the clinical studies, initial safety review of adverse events, medical review of clinical data, management of drug safety vendors, review of source documents, preparation of documents for submission to regulatory authorities, medical monitoring support to clinical trial sites for questions related to clinical trial, and emergency unblinding. This individual will apply deep medical and clinical expertise to ensure high-quality decision-making and will work collaboratively across the enterprise to align drug development programs with leadership goals and ensure efficient, end-to-end execution of clinical development plans. This role is pivotal in shaping leading-edge clinical science applied to CNS drug development. The individual will build and lead the MM and PV group in this role.

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the SVP, Clinical Research and Development.

Key responsibilities of this role include, but are not limited to:

• Provide medical leadership to the Clinical group and multi-disciplinary study teams.

• Manage and lead the MM & PV group, manage resources, and budget pertinent to the PV activities.

• Serve as a medical monitor/advisor of ongoing clinical trials.

• Ensure compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory requirements, for the processing and reporting of adverse events in coordination with regulatory affairs.

• Responsible for the overall clinical risk management and safety surveillance of all future investigational products.

• Provide medical review and advice of post marketing safety data.

• Prepare/oversee medical monitoring plans and present the study protocol’s safety in the IM meetings and site initiation activities.

• Act as 24/7 available medical contact person for questions related to clinical trial and for emergency unblinding.

• Medical review of coding, ensure accuracy of MedDRA coding of adverse events’ terms, medical history, and WHO Drug coding of concomitant medications.

• Medical review of eCRF related to clinical and safety data.

• Medical review of individual case safety report (ICSR): adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), adverse drug reactions (ADR), causality assessment, signal detection, case narrative, aggregate reports, medical review of listings of safety data.

• Write/review the relevant safety sections of the NDA and different types of regulatory meeting packages.

• Provide medical input and review of annual reports, PADER, PSUR, DSUR, other benefit risk assessment reports, updates of package insert/label, summary of product characteristics, and investigator’s brochure.

• Prepare and review the answers to questions from Health Authorities, medical input in Risk Management Plan (RMP).

• Participate in DSMB preparation and activities.

• Collaborate with clinical operations and clinical research to optimize study designs for operational efficiency, ensuring timely and cost-effective delivery.

• Oversee the design and execution of clinical research studies and review key clinical documents (e.g., protocols, clinical study reports, regulatory submissions).

• Maintain current knowledge of all applicable drug safety guidelines and regulations (FDA, ICH, IRB, EMA).

• Establish the necessary MM &PV SOPs and work guidance.

Qualifications:

• MD or DO, with relevant post-graduate clinical training.

• US board-certified physician (preference in psychiatry) with 10+ years of relevant work experience in pharmaceutical/biotech industries.

• Experience in NDA and IND submissions is preferred.

• Knowledge of medical and therapeutic terminology.

• Deep understanding of the drug development process (preferred in CNS therapeutic areas).

• Strong knowledge of regulatory requirements (GCP, ICH guidelines) and worldwide safety regulations.

• Experience in managing MM &PV budgets and financial risk in clinical research.

• Ability to review emerging data and proactively ensure the delivery of high-quality study results.

• Skilled communicator and leader, able to articulate ideas clearly and integrate team feedback.

• Excellent writing skills, and ability to convey moderately complex technical information clearly to others.

• Ability to work independently in a dynamic and fast-moving environment.

• Proficient in meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Science, and Health Care Provider

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