Senior Manager, Pharmacovigilance

Pharmacovigilance Waltham, Massachusetts


Description

Position Summary:

The Senior Manager is a key member of our pharmacovigilance team and is responsible for maintaining compliance with regulatory reporting compliance, presentation of safety data, managing standard PV procedures and assisting in the oversight of vendor services and PV agreements.

Key Responsibilities Include:

  • Work with cross-functional team members to ensure accurate and efficient safety data collection from clinical trials and post-marketing surveillance
  • Assist in the support and oversight of pharmacovigilance service vendors
  • Assist in production and revision of clinical trial documents and report forms
  • Assist in safety review, data reconciliation and signal evaluation activities
  • Search and retrieve safety data from safety and clinical trial databases for inclusion in external and internal reports
  • Draft aggregate data summaries for medical review
  • Contributes to periodic safety and clinical study reports and reviews case safety narratives
  • Assist in GCP and GVP inspection readiness and conduct
  • Providing PV input as an ad hoc study team member
  • Maintain company Reference Safety Information in line with company medical opinion
  • Assist in standard procedure development and maintenance
  • Work with clinical operations colleagues to provide safety-related communication to investigational sites and ethics committees
  • Work with quality assurance colleagues to address safety-related GCP compliance issues and implement corrective action

Education, Registration & Certification:

  • Healthcare or life sciences degree

Experience:

  • At least 5 years prior experience in the Pharma/Biotech industry is required, with at least 2 years in pharmacovigilance

Skills, Knowledge & Abilities:

  • Comfortable working independently with supervision
  • Knowledge of pharmacovigilance regulations and guidelines
  • Demonstrated understanding of safety database, medical literature and electronic data capture technology  
  • Highly organized, results driven, problem solver
  • Superior written and oral communication skills and the ability to work with different levels of management in several departments 
  • Highly motivated with the ability to be flexible in a fast-paced environment 

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more. 

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.