Pharmacovigilance Manager (Boston, MA; Dallas, TX; ...)We are seeking an experienced and proactive Pharmacovigilance Manager to join our team on a contract basis. In this role, you will be responsible for managing all aspectsof drug safety activities, ensuring compliance with global pharmacovigilance regulations and company policies. You will lead cross-functional teams in the assessment, documentation, and reporting of safety data to support the overall safety and efficacy of our products.Key Responsibilities:
- Oversee and manage the collection, assessment, and reporting of adverse events, ensuring compliance with global pharmacovigilance regulations, including FDA and EMA standards.
- Develop, implement, and maintain pharmacovigilance processes and SOPs to ensure robust safety reporting and documentation.
- Lead signal detection activities, risk assessments, and risk management plan development to identify potential safety concerns and recommend action.
- Collaborate with cross-functional teams (including clinical, regulatory, and quality) to ensure alignment and accuracy in all drug safety processes.
- Act as the primary point of contact with regulatory authorities for all pharmacovigilance matters, including safety queries, regulatory submissions, and inspection readiness.
- Provide guidance and training to internal teams and external partners on pharmacovigilance policies, best practices, and regulatory requirements.
- Manage and oversee the preparation of safety reports, including PSURs, DSURs, RMPs, and other regulatory documents.
- Participate in safety data review meetings and provide input on safety strategy and the overall risk-benefit profile of products.
- Stay up-to-date with changes in global pharmacovigilance regulations and implement necessary updates to internal processes and procedures.
- Ensure the maintenance of accurate and complete safety databases and records, complying with company standards and regulatory requirements.
- Coordinate and lead audits and inspections related to pharmacovigilance activities to ensure adherence to all applicable standards.
- Mentor and support team members and colleagues in pharmacovigilance operations and safety surveillance.Qualifications:
- Bachelor's degree in life sciences, pharmacy, nursing, or a related field; advanced degree preferred.
- 5+ years of experience in pharmacovigilance, drug safety, or a related area within the pharmaceutical or biotech industry.
- Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines.
- Proven leadership skills with the ability to manage cross-functional teams and multiple projects effectively.
- Excellent communication skills and ability to build strong relationships with regulatory bodies, internal teams, and external partners.
- Strong analytical and problem-solving skills, with a keen attention to detail and the ability to assess safety data accurately.
- Proficiency in safety databases, regulatory submission systems, and Microsoft Office Suite (Word, Excel, PowerPoint). #J-18808-Ljbffr