Pharmacovigilance Manager
Pharmaceutical Manufacturing
Boston, Massachusetts
$120,000 – $160,000 per year + 10% performance bonus
Full time/ direct hire
The Pharmacovigilance Manager will lead and manage all pharmacovigilance activities to ensure the safety and efficacy of the company's pharmaceutical products. This role is critical in overseeing adverse event reporting, risk management, and compliance with global regulatory requirements. The ideal candidate will have extensive experience in drug safety, a strong understanding of regulatory guidelines, and proven leadership skills to guide a team of pharmacovigilance professionals.
Key Responsibilities:
Pharmacovigilance Operations:
Adverse Event Reporting:
- Oversee the collection, assessment, and reporting of adverse events from all sources (clinical trials, post-marketing, literature, etc.).
- Ensure timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities in compliance with global regulations.
Safety Data Management:
- Manage and maintain pharmacovigilance databases, ensuring data quality and integrity.
- Implement and optimize safety systems and processes for efficient pharmacovigilance operations.
Risk Management:
- Develop and execute Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
- Conduct signal detection, assessment, and management activities to identify and mitigate potential safety risks.
Regulatory Compliance:
Regulatory Submissions:
- Prepare and review safety sections of regulatory submissions, including INDs, NDAs, PSURs, DSURs, and other periodic reports.
- Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH guidelines).
Audit and Inspection Readiness:
- Lead preparation for regulatory inspections and audits related to pharmacovigilance activities.
- Address and resolve any findings or compliance issues identified during inspections.
Team Leadership and Development:
Team Management:
- Supervise and mentor a team of pharmacovigilance professionals, fostering a collaborative and high-performance work environment.
- Assign tasks, set performance goals, and conduct regular evaluations to support team growth.
Training and Education:
- Develop and deliver pharmacovigilance training programs for internal staff and external partners.
- Stay current with industry trends and best practices to enhance team expertise.
Cross-Functional Collaboration:
Internal Partnerships:
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments to support product safety.
- Provide pharmacovigilance input into clinical study protocols, informed consent forms, and other study documents.
External Communication:
- Liaise with external partners, including contract research organizations (CROs), regulatory authorities, and business partners on safety-related matters.
- Represent the company in industry forums and professional meetings related to pharmacovigilance.
Qualifications:
Education:
- Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related field.
- Advanced degree (Master's, PharmD, MD) preferred.
Experience:
- Minimum of 7-10 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotechnology industry.
- At least 3 years in a managerial or supervisory role.
- Proven experience with global pharmacovigilance regulations and reporting requirements.
Skills and Competencies:
- Technical Expertise:
- In-depth knowledge of pharmacovigilance principles, adverse event reporting processes, and regulatory guidelines.
- Proficiency with safety databases and software (e.g., Argus Safety, ArisGlobal).
Preferred Qualifications:
- Experience in specific therapeutic areas relevant to the company's product portfolio.
- Familiarity with electronic submission processes and pharmacovigilance system master files.
- Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).