Pharmacovigilance Manager

Pharmacovigilance Manager - Permanent - Boston, MA

Proclinical is partnering with a biotech company to recruit a PV Manager who will be will be responsible for Safety Project Management in coordination with safety operations and case processing.

Please note, applicants must have legal authorization to work in the United States.

The Pharmacovigilance Manager's responsibilities will be:

• Work with the Head of Safety and Safety team members to plan, coordinate, and facilitate any safety-related projects, including case management workflows, process improvements, training, etc.
• Develop and maintain timelines, ensuring deliverables are met within internal and external timelines
• Support the coordination and performance of signal management activities
• Support the performance of case processing activities as appropriate
• Support quality (control) initiatives including related to case processing, document development and across other activities and deliverables
• Support adverse event reporting compliance, including serious adverse events (SAEs) and periodic safety updates
• Assist in the preparation of aggregate safety reports, including DSURs, etc.
• Support the PV Operations Lead in safety activities, including PV budgets, standing operating procedure (SOP) and work instruction (WI) development, etc

Skills & Requirements:

• Bachelors' degree required, life sciences degree is preferred
• Minimum of 5 years of experience in drug safety/pharmacovigilance quality assurance or
• compliance within the pharmaceutical or biotech industry
• Knowledge and understanding of US, EU and ICH guidelines and experience of working to GvP & GxP
• Proficiency in conducting internal audits, risk assessments, and compliance monitoring activities preferred
• Excellent understanding of pharmacovigilance concepts and terminology
• Proficient in both written and spoken English, with excellent written and verbal communication skills to interact across multiple functions
• Knows when and how to speak up and appropriately raise issues to the team and propose solutions to management
• Keeps team members, departmental colleagues (as appropriate) and management fully apprised of project / initiative status and issues
• Demonstrated credibility: diplomatic, decisive, straightforward, honest

Personal Qualities:

• Able to take direction with high self-motivation to support and attain goals in a fast-paced environment
• Experienced team member
• Well-developed interpersonal, analytical, computer, and oral and written communication skills
• Ability to contribute to analysis and problem solving through within a team environment
• Thoughtful collaborator with the ability to work effectively with internal and external stakeholders
• Strong organizational and time management skills and the ability to function effectively in a team/matrix environment
• Demonstrated professionalism and adherence to high ethical standards

Other Experience/Abilities:

• Is proactive, a fast-learner, is flexible and adept at working in a fast-paced, changing environment with strong problem solving and analytical skills

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.