Job description

With a startup spirit and 100,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it. Come, transform with us.

Are you the one we are looking for?

We are inviting applications for the role of Pharmacovigilance Associate.

Location: Bridgewater’s, NJ - Onsite from Day1, Fully vaccinated

Job Description: This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance, and complaint handling is required. Maintains onsite sample room and mailroom as per departmental SOP.

Responsibilities

· Prioritizes complaints about data entry and processing.

· Understands the importance of data entry of complaints within the required timeframe.

· Understands special details for handling each product within the department.

· Understands departmental process flow on drug and device complaints.

· Proficient with the use of all databases within the department (i.e.. ACES-Siebel, Global PTC Database, Microsoft Office).

· Prepares appropriate correspondence for complaints.

· Identifies and prepares appropriate mailers for use in retrieving the complaint samples.

· Produces daily reports for follow-up activity.

· Reviews and processes reconciliation with Pharmacovigilance.

· Process complaint samples upon receipt

· Identifies and handles lot discrepancies correctly with returned complaint samples.

· Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.

· Identifies and prepares complaint samples for shipping to manufacturing sites.

· Orders departmental supplies.

· Identifies complaints about field alert reporting

· Performs QC Checks

· Provide customer service to consumers, health care professionals, and internal/external departments regarding individual complaints.

· Provide support to US Product Quality Complaint Managers/Director during audits by FDA, other regulatory agencies, third parties, and internal groups.

· Notifies interested departments (including manufacturing sites QA, commercial, regulatory, supply chain) upon receipt of complaints.

· Understands the FDA complaints regulations for the drug products and medical devices.

· Maintains monthly reports as needed

· Provide complaints support to other company departments including but not limited to customer service, medical information, Pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management

· Maintains sample room and mailroom as per departmental SOP.

Qualifications we seek in you!

Minimum Qualifications

· Associate degree with experience in a pharmaceutical, administrative, and/or coordinator environment or bachelor’s degree (science discipline preferred) + years of experience in a pharmaceutical, administrative, and/or coordinator environment.

· Area of specialization: Health or Life Sciences preferred

Preferred Qualifications/Skills

· Excellent Verbal and Written Communication skills.

· Excellent interpersonal skills.

· Understanding of Good Documentation Practices

· Good organizational and prioritization skills.

· Ability to multi-task in a fast-paced environment

· Adept at attention to detail

· Strong understanding of Good Documentation Practices

· Familiarity with medical terminology.

· Work effectively and cooperatively with others; establish and maintain good working relationships.

· Computer literate-proficient in use of Microsoft Office. Must be able to understand and utilize complaint database software and reporting tools.

· Ability to multitask in a highly stressful environment.

Job Type: Full-time

Pay: $45,000.00 - $50,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Bridgewater, NJ 08807: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Pharmacovigilance: 2 years (Required)

Work Location: One location

blackflymedia.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blackflymedia.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, blackflymedia.com is the ideal place to find your next job.