Product Safety Manager

The Specialized Recruiting Group is searching for a Pharmacovigilance and Product Safety Manager for a growing pharmaceutical and medical device company in North Raleigh. This role is expected to start off contract and is 3 days per week on-site. There is flexibility for which days of the week the person would work.

Schedule: 3 days (24 hours) per week (flexible)

Location: On-site in Raleigh

Position Overview:

This role is responsible for all activities related to the collection, processing, evaluation, and regulatory reporting of adverse events (AEs), serious adverse events (SAEs), adverse events of interest (AEIs), and pregnancy reports for both marketed and investigational products. The position covers a wide range of product categories, including medical devices, cosmetics, and over-the-counter (OTC) products.

Key Responsibilities:

Adverse Event Case Management

• Independently analyze, process, and document adverse event reports from multiple sources for various product types.
• Review and assess complex medical information and laboratory data, write narrative summaries, and conduct necessary follow-up activities.

Clinical Study Safety Oversight

• Participate in clinical project teams, providing input on adverse event collection during clinical trials.
• Develop and maintain safety sections of clinical trial protocols, Investigator Brochures, and Safety Management Plans.
• Support end-of-study safety activities, including SAE reconciliation and final documentation.

Regulatory Compliance & Reporting

• Ensure timely and accurate submission of individual AE and SAE case reports to global regulatory authorities, partners, and affiliates.
• Maintain compliance with Safety Data Exchange Agreements (SDEAs) and relevant international reporting regulations.

Safety Data Evaluation

• Perform detailed medical and pharmacological evaluations of individual case reports.
• Verify MedDRA/IMDRF coding accuracy and assess causality, seriousness, and expectedness.
• Identify and communicate potential safety signals or trends to appropriate stakeholders.

Literature Surveillance

• Conduct and document periodic and ad hoc literature reviews to identify potential reportable safety information or emerging signals.

Database Management

• Maintain proficiency in validated safety databases (e.g., Argus, ARISg, SIAB).
• Perform data entry, generate reports, execute searches, and support regulatory or management queries.

Process Improvement & Documentation

• Contribute to the development and review of standard operating procedures (SOPs), work instructions, and guidance documents to ensure regulatory compliance.

Training & Support

• Provide training to investigators, internal staff, and partners on adverse event reporting requirements.
• Support internal and external audits as needed.

Collaboration

• Work cross-functionally with Quality, Clinical, Regulatory, and Medical Affairs teams to ensure consistent global safety and vigilance practices.
• Support regional safety staff to meet international vigilance obligations.

Qualifications:

Minimum Requirements

• Bachelor’s degree in a scientific or healthcare-related discipline (RN/PharmD preferred).
• 5 years of experience in drug safety or medical device vigilance within an industry or equivalent setting.
• Strong working knowledge of FDA and EU regulations governing clinical safety and vigilance.
• Experience with validated safety databases (e.g., Argus, ARISg) and coding dictionaries such as MedDRA, WHODrug, and IMDRF.
• Excellent analytical, organizational, and project management skills.
• Strong written and verbal communication abilities.

Preferred Qualifications

• Direct healthcare experience with injectable products.
• Experience with document management systems (e.g., EDMS, eTMF).
• Vendor management experience.
• Proven ability to build relationships and solve problems in a collaborative environment.

Please send your resume today for immediate consideration!