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Drug Safety Manager Jobs in Silver Spring, MD (NOW HIRING)

ArchKey Solutions LLC

Safety Manager

Clinton, MD

Provides oversight of DOT regulatory compliance, including driver's qualification files, DOT drug testing and driver safety. Manages OSHA, MSHA, DOT and other regulatory inspections and related ...

New

ArchKey Solutions

Safety Manager

Dulles, VA · On-site

Provides oversight of DOT regulatory compliance, including driver's qualification files, DOT drug testing and driver safety. Manages OSHA, MSHA, DOT and other regulatory inspections and related ...

New

ArchKey Solutions LLC

Safety Manager

Dulles, VA

Provides oversight of DOT regulatory compliance, including driver's qualification files, DOT drug testing and driver safety. Manages OSHA, MSHA, DOT and other regulatory inspections and related ...

New

ArchKey Solutions

Safety Manager

Dulles, VA · On-site

Provides oversight of DOT regulatory compliance, including driver's qualification files, DOT drug testing and driver safety. Manages OSHA, MSHA, DOT and other regulatory inspections and related ...

New

ArchKey Solutions

Safety Manager

Clinton, MD

Provides oversight of DOT regulatory compliance, including driver's qualification files, DOT drug testing and driver safety. Manages OSHA, MSHA, DOT and other regulatory inspections and related ...

New

ArchKey Solutions

Safety Manager

Clinton, MD · On-site

Provides oversight of DOT regulatory compliance, including driver's qualification files, DOT drug testing and driver safety. Manages OSHA, MSHA, DOT and other regulatory inspections and related ...

New

Southland Industries

Safety Manager

Dulles, VA · On-site

Position Summary The site Safety Manager assists the Division Safety Manager and leadership in ... All employment offers are contingent upon successful drug tests, background checks, and ...

Clark Construction Group

Safety Manager

Mclean, VA

As a Safety Manager, you will ensure the safety of employees, trade partners, and the general ... A Drug Free Workplace: Clark promotes a drug free workplace. A pre-employment drug "fitness for ...

Transdev

Safety Manager

Baltimore, MD · On-site

$84K - $105K/yr

Safety & Training Manager NOTE: The following position is for a proposed new/future business within ... Directs the location drug & alcohol program to include random drug testing and ensures all files ...

New

Transdev

Safety Manager

Baltimore, MD · On-site

$84K - $105K/yr

Safety & Training Manager NOTE: The following position is for a proposed new/future business within ... Directs the location drug & alcohol program to include random drug testing and ensures all files ...

New

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Drug Safety Manager information

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$38.3K

$88.9K

$141.1K

How much do drug safety manager jobs pay per year?

As of Aug 19, 2026, the average yearly pay for drug safety manager in Silver Spring, MD is $88,875.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,700.00 and $106,000.00 per year, depending on experience, location, and employer.

What does a drug safety manager do?

A Drug Safety Manager is responsible for overseeing the collection, evaluation, and reporting of data related to the safety of pharmaceutical products. They ensure compliance with regulatory requirements and help identify, assess, and mitigate risks associated with medications. Their role often includes managing a team, developing safety protocols, and communicating findings to regulatory authorities and internal stakeholders. By maintaining vigilance over drug safety, they help protect patient health and support the ongoing improvement of pharmaceutical products.

What are the key skills and qualifications needed to thrive as a drug safety manager?

To thrive as a Drug Safety Manager, you need expertise in pharmacovigilance, regulatory compliance, and drug safety reporting, typically backed by a degree in pharmacy, life sciences, or a related field. Familiarity with safety databases (such as Argus or ARISg), MedDRA coding, and ICH-GCP guidelines is commonly required, along with relevant certifications like those from the Drug Information Association (DIA). Strong analytical thinking, attention to detail, and effective communication skills are crucial for managing safety data and collaborating with cross-functional teams. These skills ensure accurate safety monitoring, regulatory adherence, and the protection of patient well-being throughout a drug’s lifecycle.

What are the main challenges drug safety managers face when ensuring compliance with global pharmacovigilance regulations?

Drug Safety Managers often navigate complex and evolving international regulations to ensure a company's pharmacovigilance practices are compliant. They must coordinate with cross-functional teams to gather timely and accurate safety data, manage case processing workflows, and prepare regulatory submissions under strict deadlines. Staying updated on changing global requirements and aligning internal processes accordingly can be challenging, but is crucial for patient safety and product success. Effective communication, attention to detail, and proactive risk management are key in overcoming these challenges.

What is the difference between Drug Safety Manager vs Pharmacovigilance Specialist?

AspectDrug Safety ManagerPharmacovigilance Specialist
CredentialsTypically requires a degree in pharmacy, life sciences, or related field; certifications like PV or REMS are commonSimilar educational background; often holds certifications in pharmacovigilance or drug safety
Work EnvironmentLeads drug safety teams, manages safety data, and oversees compliance within pharmaceutical companiesFocuses on collecting, analyzing, and reporting safety data, often working under supervision
Industry UsageUsed in pharmaceutical and biotech companies for overseeing safety programsCommonly used in regulatory agencies and contract research organizations

While both roles involve drug safety and require similar qualifications, the Drug Safety Manager typically has a leadership role overseeing safety operations, whereas the Pharmacovigilance Specialist focuses on data collection and analysis. The manager has broader responsibilities, including team management and strategic planning.

What are the most commonly searched types of Drug Safety jobs in Silver Spring, MD?

The most popular types of Drug Safety jobs in Silver Spring, MD are:

What are popular job titles related to Drug Safety Manager jobs in Silver Spring, MD?

For Drug Safety Manager jobs in Silver Spring, MD, the most frequently searched job titles are:

What job categories do people searching Drug Safety Manager jobs in Silver Spring, MD look for?

The top searched job categories for Drug Safety Manager jobs in Silver Spring, MD are:

What cities near Silver Spring, MD are hiring for Drug Safety Manager jobs?

Cities near Silver Spring, MD with the most Drug Safety Manager job openings:

Drug Safety Manager jobs near you

Senior Manager, Drug Safety and Medical Monitoring

Supernus Pharmaceuticals, Inc.

Rockville, MD • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 29 days ago

Job description

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.
Job Summary:
The Senior Manager of Drug Safety and Medical Monitor will provide medical monitoring support to the drug safety and medical monitoring team. They will conduct medical reviews of clinical research data, safety alerts and notification, SAE narratives, and pertinent source documents. Responsibilities also include reviewing and processing documents relevant to medical monitoring activities and providing medical input to internal teams such as Clinical Development, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Medical Writing.
Essential Duties & Responsibilities:
  • Conduct medical reviews of clinical trial safety data and provide input to internal teams (Clinical Development, Drug Safety, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, and Medical Writing).
  • Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
  • Conduct medical reviews and perform user acceptance testing of electronic case report forms (eCRF) to ensure medical consistency of clinical and safety data collection.
  • Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File, shared drive, etc.) for all applicable clinical trials.
  • Conduct medical reviews of Tables/Listings/Figures (TLF), clinical study reports (CSR), and provide input to Clinical Development, Medical Writing, Data Management and Clinical Operations Teams.
  • Review, categorize, and maintain the Medical Monitoring Outlook folder.
  • Review and file safety alerts and notifications and communicate notable values to the Medical Monitoring Lead.
  • Track and ensure timely review of the protocol deviations for all applicable clinical trials.
  • Review coding to ensure accuracy of MedDRA coding for adverse event terms, medical history, and procedures, and WHO Drug coding for concomitant medications.
  • Conduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead.
  • Prepare and review Medical Monitoring Plans and Safety Management Plans, and participate in Site Initiation Visits.
  • Provide medical input and review of annual reports, PADERs, PSURs, DSURs, other benefit-risk assessment reports, updates to package inserts/labels, and Summaries of Product Characteristics (SmPCs).
  • Participate in and present at Clinical Development training and meetings; prepare meeting agendas and minutes, as applicable.
  • Draft and review Standard Operating Procedures (SOPs).
  • Review Statements of Work and vendor budgets for all applicable medical monitoring tasks and escalate issues to relevant team members.
  • Support the Drug Safety and Medical Monitoring team in the preparation and review of safety reports and data, e.g., cumulative SAE reports, safety database reports, MedWatch Reports, and other reports, as deemed necessary.
  • Maintain up-to-date knowledge of all applicable drug safety guidelines and regulations (FDA, ICH, MHRA, EMA) and apply them to medical monitoring tasks relevant to disease areas and therapeutic areas for both marketed drugs and drugs in development.
  • Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures
  • Perform other duties as assigned.

Supervisory Responsibilities:
  • N/A.

Knowledge & Other Qualifications:
  • Degree in a medical field, MD, DO, MBBS, Nurse Practitioner, or equivalent is required with a minimum of three years of relevant experience.
  • Knowledge of medical and therapeutic terminology, including WHO Drug and MedDRA dictionaries.
  • Experience in medical monitoring and medical review.
  • Experience in authoring Standard Operating Procedures.
  • Experience with clinical and safety databases, and Veeva Systems.
  • Working knowledge of ICH guidelines and other global safety regulations.
  • Demonstrated working knowledge of FDA regulations relevant to patient safety and adverse event reporting, including periodic safety reporting.
  • Working knowledge of principles and concepts associated with patient safety case-handling processes, including regulatory reporting requirements, policies, processes, and procedures.

Other Characteristics:
  • Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
  • Ability of having an innovative and dynamic approach to work.
  • A self-starter able to work independently but comfortable working in a team environment.
  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
  • Capable of performing other duties as assigned by Management.
  • Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:
  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
  • The worker is required to have close visual acuity to perform activities such as preparing and analyzing data and figures, transcribing, viewing a computer screen, iPad, or other electronic device, and extensive reading. Strong attention to detail is essential to ensure accuracy and consistency in all tasks involving data review and documentation.
  • The worker is not substantially exposed to adverse environmental conditions.

Compensation:
At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $131,000 to $155,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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