Job Description
Position Summary:
Reporting to the Director PV Operations, the Manager will support vendor oversight and drug safety operations across the clinical development and post market programs. 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 safety SOPs and policies, best industry standards and applicable regulations.
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 safety on clinical development teams and other program teams, as assigned.
- Provides sponsor oversight of case processing by outsourced vendors, including supporting review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
- Supports interactions with contract service providers for case processing and quality management activities.
- Provides safety operations support for external submissions of drug and device reports.
- Ensures compliant exchange of safety data between Apellis and its partners.
- Works with PV Compliance, QA, other cross-functional teams to maintain a state of high PV inspection readiness across all regions/countries.
- Supports audits and regulatory inspections and related activities.
Education, Registration & Certification:
- Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences preferred.
Experience:
- Minimum of 2-4 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 marketed products or products in development.
- Safety database, MedDRA coding and/ or data entry experience.
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. 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 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 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.
Job Tags
Contract work, Summer work, Local area, Flexible hours,