Senior Manager, Pharmacovigilance Operations

Position Summary:

Reporting to the Director of PV Operations, the Senior Manager of PV Operations will play a key role in drug safety operations across clinical development and post market programs. The Senior Manager contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with safety SOPs and policies, industry best practice, and applicable regulations. Responsible for oversight of case processing activities performed externally by Drug Safety and Pharmacovigilance’s vendors, in both the post-marketing and clinical trials settings. Will participate in regulatory inspections and company audits and may act as subject matter expert for global case management workflow and processes; prepares responses to audit findings that concern the safety department.

Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

• Participates in the daily management and execution of Pharmacovigilance operations.
• Provides sponsor oversight of case processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans. Sets case handling standards and performs relevant case handling activities as needed, e.g. inline QC and approving logical deletions.
• Represents safety on clinical development teams leading operational activities, including SAE data reporting and reconciliation between the safety and clinical database.
• Ensures compliant exchange of safety data between Apellis and its partners.
• Monitors compliance with regulations, PV agreements and internal SOPs in collaboration with PV Compliance.
• Collaborates with contract service providers for case processing, aggregate reporting and quality management activities.
• Contributes to the maintenance of metrics, key performance indicators (KPIs) and related activities.
• Completes late case investigations and owns case management related CAPAs.
• Collaborates cross functionality in systems initiatives and partakes in implementation.
• Participates in regulatory inspections and company audits; prepares responses to audit findings that concern the safety department.
• May act as the subject matter expert for global case management workflow and processes during audits and inspections.

Education, Registration & Certification:

• Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences.

Experience:

• Minimum of 5 years of relevant experience within the biotech or pharmaceutical industry.
• Minimum of 3 years of experience in drug safety/Pharmacovigilance.
• Experience working with CROs, vendors, and relationship management preferred.
• Global pharmacovigilance operations experience with products in development.

Skills, Knowledge & Abilities:

• Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
• Strong analytical and problem-solving skills with superb attention to detail.
• Strong verbal, written technical communication and presentation skills.
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization. 
• Proven ability to work within a cross-functional, matrixed team.

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:

• Occasional travel may be required for inspections, audits, vendor meetings, or other business-related activities. Travel is expected to be infrequent and planned in advance.

Benefits and Perks:

Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies.

The targeted base salary range for this position is $151,000- $227,000 per year. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions