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Contract Drug Safety Associate Jobs in Michigan (NOW HIRING)

Associate degree or equivalent experience * Strong analytical and problem-solving skills * Clear ... Moeller Aerospace is a Drug-Free Workplace. All new team members must complete pre-employment drug ...

Oversee the company's mandatory post-accident drug screening. * Implement the Return-to-Work ... Bachelor's or associate's degree in environmental safety & health, or 3-5 years of relevant ...

Oversee the companys mandatory post-accident drug screening. * Implement the Return-to-Work Program ... Bachelors or associates degree in environmental safety & health, or 3-5 years of relevant ...

Oversee the company's mandatory post-accident drug screening. * Implement the Return-to-Work ... Bachelor's or associate's degree in environmental safety & health, or 3-5 years of relevant ...

Solar Contract Carpet is a leading provider of multi-family, commercial, and residential flooring ... safety procedures. · Assist with incoming and outgoing shipments, including packaging, labeling ...

... Drug and Alcohol Substance Abuse Program. Develops and conducts employee safety and health training programs. Conducts detailed site safety and health inspections. Manages project security contracts ...

SPM Contract Manager II

Detroit, MI

$87K - $117K/yr

... safety, and wellbeing. Are you ready to make that kind of difference? Bring your energy to DTE ... Associates degree in supply chain management, logistics, business administration, engineering or ...

SPM Contract Manager II

Detroit, MI · On-site

$87K - $117K/yr

... safety, and wellbeing. Are you ready to make that kind of difference? Bring your energy to DTE ... Associates degree in supply chain management, logistics, business administration, engineering or ...

WHAT WE NEED: 1. High School Diploma. 2. Associates degree preferred 3. Evidence of ability to ... Per Master Agreement View Avondale Contract Agreements (Current Bargaining Agreements) WHY WORK FOR ...

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Contract Drug Safety Associate information

What does a contract drug safety associate do?

A Contract Drug Safety Associate is responsible for monitoring, collecting, and analyzing information about the safety of pharmaceutical products. They work on a contractual basis, often for pharmaceutical companies or clinical research organizations, to ensure that adverse events and potential side effects are properly documented and reported to regulatory authorities. Their duties may include data entry, case processing, regulatory reporting, and supporting safety audits. These professionals help ensure patient safety and compliance with regulatory requirements throughout the drug development and post-marketing process.

What are the key skills and qualifications needed to thrive as a contract drug safety associate, and why are they important?

To thrive as a Contract Drug Safety Associate, you need a solid understanding of pharmacovigilance principles, adverse event reporting, and experience with regulatory guidelines, often supported by a degree in life sciences or pharmacy. Familiarity with drug safety databases (such as Argus or ARISg), MedDRA coding, and compliance with FDA and EMA regulations is typically required. Strong attention to detail, effective communication, and the ability to manage time-sensitive tasks are crucial soft skills in this role. These competencies ensure accurate safety data management, regulatory compliance, and the protection of patient well-being.

What are some common challenges faced by contract drug safety associates, and how can they be addressed?

Contract Drug Safety Associates often face challenges such as adapting quickly to new company protocols, managing high volumes of case processing within tight timelines, and staying updated with evolving regulatory requirements. Since contract roles may involve working with multiple teams or transitioning between projects, strong communication skills and adaptability are essential. Proactively seeking clarification, utilizing available training resources, and maintaining organized documentation can help overcome these challenges and ensure high-quality work in this fast-paced environment.

What is the difference between Contract Drug Safety Associate vs Contract Pharmacovigilance Associate?

AspectContract Drug Safety AssociateContract Pharmacovigilance Associate
CertificationsTypically requires life sciences or healthcare-related certificationsSimilar certifications, often including pharmacovigilance training
Work EnvironmentPharmaceutical companies, CROs, or biotech firmsSame as Drug Safety Associate, often in clinical or regulatory settings
Industry UsageUsed in drug safety monitoring and adverse event reportingUsed in drug safety, risk management, and regulatory compliance
Job FocusMonitoring adverse events, data entry, case processingMonitoring, reporting, and risk assessment of drug safety data

The Contract Drug Safety Associate and Contract Pharmacovigilance Associate roles are closely related, both focusing on drug safety and adverse event management within pharmaceutical and biotech industries. The main difference lies in terminology used by employers, but their responsibilities, work environment, and required certifications are very similar.

What are popular job titles related to Contract Drug Safety Associate jobs in Michigan?

For Contract Drug Safety Associate jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Contract Drug Safety Associate jobs in Michigan look for?

The top searched job categories for Contract Drug Safety Associate jobs in Michigan are:

What cities in Michigan are hiring for Contract Drug Safety Associate jobs?

Cities in Michigan with the most Contract Drug Safety Associate job openings:

Senior Pharmacovigilance System Architect (Argus Administrator) - US

Ann Arbor, MI • On-site

MMS
Pharmaceutical and Medicine Manufacturing • 1 - 10 employees

Full-time

Re-posted 17 days ago


Job description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Senior Pharmacovigilance System Architect

We are recruiting for an experienced Pharmacovigilance System Architect (Argus Administrator SME) to join our US team.

Roles & Responsibilities

  • Serves as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance and daily support.
  • Performs installations, upgrades, configuration of reporting rules, and E2B reporting via gateway technologies (including set-up and configuration of Axway Gateway Interchange).
  • Provides support for all systems associated with PV and drug safety.
  • Performs updates to Argus configuration and processes as per changing EudraVigilance regulations.
  • Provides support and execution of activities related to EudraVigilance testing for various clients.
  • Performs case migration/database transfers, file importing and supports other case processing activities.
  • Provides leadership in executing Argus upgrades and related activities.
  • Provides administrator support for other safety databases (such as ARISg).
  • Performs periodic coding dictionary (MedDRA & WHO drug) updates for Argus.
  • Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies.
  • Writes procedural documents including Standard Operating Procedures (SOP), Work Practice Documents, and Data Entry Manuals for Argus Safety.
  • Generates case processing metrics, reviews and makes suggestions and supports process improvement implementation.
  • Maintains technical expertise of regulatory requirements and ensures alignment with company working practices.
  • Assists with business development and capabilities efforts as needed.
  • Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client capabilities as PV/drug safety systems SME.
  • Strong understanding and experience working with Argus configuration and study set up.
  • Strong understanding of global case processing and SAE reporting.
  • Strong understanding of global clinical trial development and data.

Requirements

  • College graduate Information Technology discipline or related field, or relevant experience.
  • Minimum of 5 years’ experience in Information Technology or similar field required.
  • Expert knowledge of scientific principles and concepts.
  • Reputation as emerging leader in field with sustained performance and accomplishment.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Familiarity with current ISO 9001 and ISO 27001 standards preferred.
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
  • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

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M. M. S. logo

About M. M. S.

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

1 - 10 Employees

Headquarters location

Los Angeles, CA, US

Year founded

1980