Position Summary:
Reporting to the Head of Pharmacovigilance (PV) Operations, SaBR (Safety and Benefit Risk management) 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, with a focus 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).
Key Responsibilities Include:
- Participates in the daily management and execution of PV operations across clinical trial and post-market programs.
- Monitors compliance with regulations, PV agreements, and internal SOPs.
- Support SaBR on clinical development teams and other program teams, as assigned.
- Provides sponsor oversight of case processing outsourced to vendors, including direct workflow review/ monitoring, review of system generated monitoring reports, and over oversight activities to ensure regulatory and contractual compliance.
- Supports interactions with contract service providers for case processing and quality management activities.
- Provides safety operations support for external submissions of drug, device, and combination product reports.
- Ensures compliant exchange of safety data between Apellis and its partners.
- Works with PV Compliance, Quality, and other cross-functional teams to maintain a state of high PV inspection readiness across all regions/ countries.
- Supports audits and regulatory inspections including, but not limited to FDA, MHRA, & EMA PV inspections; supports in preparing responses to audit/ inspection requests and/ or findings that concern SaBR.
Education, Registration & Certification:
- Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required.
Experience:
- 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.
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 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 https://apellis.com/careers/ 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.
