Director, Head of PV Operations

Apellis Pharmaceuticals; Waltham (MA); On-site; USD 210,000 - 242,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director, Head of PV Operations in Waltham, MA. This role involves leading pharmacovigilance operations, ensuring compliance with safety regulations, and supporting the clinical development safety processes. The successful candidate will have a healthcare degree and substantial experience in pharmacovigilance, alongside strong leadership and communication skills.

Benefits

401(k) plan with company match

Flexible time off

Paid family leave

Disability and life insurance

Qualifications

• 8-10 years prior experience in pharmacovigilance.
• Experience with clinical and commercial lifecycle phases is desirable.

Responsibilities

• Lead the PV operations team, mentoring and supporting team members.
• Manage compliance with drug safety regulations and oversee vendor services.

Skills

Leadership

Problem Solving

Communication

Knowledge of Pharmacovigilance Regulations

Organization

Safety Database Knowledge

Flexibility in Fast-paced Environment

Education

Healthcare or Life Sciences Degree

Job description

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Position Summary

The Director, Head of PV Operations is responsible for leading the PV Operations and Case Management team, managing and executing the clinical development safety processes and post-marketing pharmacovigilance processes, supporting the clinical and commercial teams, maintaining compliance with drug safety regulations, organization of medical review team meetings, creating and maintaining global and local procedures and documentation and assisting in the oversight of vendor services. The Director reports to the Senior Vice President and Head Drug Safety and Pharmacovigilance.

Position Summary

The Director, Head of PV Operations is responsible for leading the PV Operations and Case Management team, managing and executing the clinical development safety processes and post-marketing pharmacovigilance processes, supporting the clinical and commercial teams, maintaining compliance with drug safety regulations, organization of medical review team meetings, creating and maintaining global and local procedures and documentation and assisting in the oversight of vendor services. The Director reports to the Senior Vice President and Head Drug Safety and Pharmacovigilance.

Key Responsibilities Include

• Provide leadership to the PV operations team inclusive of mentoring, support, and career growth of team members.
• Working with cross-functional team members to ensure efficient and compliant safety data collection from clinical trials and post-marketing surveillance.
• Working with the Senior Vice President and Head Drug Safety and Pharmacovigilance, provides support and oversight of pharmacovigilance service vendors.
• Assist in production and review of safety sections of GCP documents (e.g. investigators’ brochure, informed consent forms).
• Assist in safety review, aggregate reporting and data reconciliation.
• Supervises the search and retrieval of safety data from safety and clinical trial databases for inclusion in external and internal reports.
• Supervises the contributions of PV Operations to periodic safety and clinical study reports and final case narratives.
• Supervises the quality review of cases processed by external vendor.
• Partner with clinical QA in GCP and GVP inspection readiness.
• Representing Safety & PV on study teams.
• Work with clinical operations colleagues to provide safety-related communication to investigational sites and ethics committees.
• Work with quality assurance colleagues to correct PV compliance issues.
• Support REMS operation activities.
• Prepare for surveillance activity after commercial launch and support sales force.
• Support safety database configuration, maintenance and system enhancement working with the PV Database Strategy and Analytics team.
  
  

Education, Registration & Certification

• Healthcare or life sciences degree.
  
  

Experience

• 8-10 years prior experience in pharmacovigilance.
• Experience with clinical and commercial lifecycle phases is desirable.
  
  

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.

Travel Requirements

• Up to 20% travel expected.
  
  

Benefits And Perks

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/benefits/ to learn more.

Company Background

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

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 pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

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