Manager - Vendor Oversight and Pharmacovigilance Operations

2 days ago

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Apellis Pharmaceuticals

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Global biopharma company leveraging courageous science, creativity, and compassion to deliver life-changing therapies.

Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000

Description

• Reporting to the Head of Pharmacovigilance (PV) Operations, the Manager of Vendor Oversight and PV Operations will support vendor oversight and drug safety operations across the clinical development programs and in the post-market setting. • The Manager contributes to the day-to-day operational activities of the department, focusing on workflow and oversight support ensuring that performed tasks comply with SaBR SOPs, policies, industry standards/ best-practices, and applicable regulations. • The manager will also directly support operational aspects of supporting the global safety database, including executing user acceptance testing (UAT).

Requirements

• Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required. • Minimum of 2 years of experience in drug safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent. • Experience working with CROs, vendors, and relationship management preferred. • Global pharmacovigilance operations experience with products in development. • Safety database, MedDRA coding and/ or data entry experience. • 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.

Benefits

• 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!