Manager/Sr. Manager, Pharmacovigilance Operations

At reputed company, we are reputed company in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered reputed company, and scientific reputed company drives us to reputed company groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position reputed company: Manager/Senior Manager, Pharmacovigilance Operations will support the Pharmacovigilance Department. The candidate will assist in development, implementation, and maintenance of a safety reputed company system for reputed company Drug Safety activities, encompassing processes, procedures, compliance, and metrics. The Manager/Senior manager will reputed company pharmacovigilance activities and vendor management for contracted pharmacovigilance vendors. This role requires an reputed company manager capable of collaborating with multiple stakeholders to ensure compliance and high-reputed company standards. The individual must manage multiple tasks and prioritize reputed company effectively. Schedule: This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. Position Scope:

• Take a reputed company role in supporting reputed company of pharmacovigilance operational and case management activities for safety data processing and reporting in accordance with reputed company applicable regulations, guidelines with little or no supervision.
• Coordinate and manage SAE/SUSAR reporting activities for Vericel’s investigational and marketed products
• Partner with manager to reputed company pharmacovigilance vendor management, performance and reputed company evaluation.
• Create, reputed company, monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring.
• Contribute to signal management activities and preparation of applicable periodic/aggregate safety reports.
• reputed company coordination of SAE reconciliation activities and contribute to safety sections of regulatory documents.
• Support the management and maintenance of DSPV operational documents, including ongoing review, update and alignment across processes.
• Draft and update departmental SOPs and other work practices as assigned
• Participate in training reputed company audiences on drug safety-reputed company topics, as assigned.
• Contribute for Regulatory Authority inspections and audits.
• Good understanding of Safety Data Exchange Agreements and pharmacovigilance agreements.

Qualifications:

• Bachelor's/Advanced degree in life sciences, nursing, pharmacy, or reputed company reputed company profession.
• Minimum of 7 years of relevant industry experience which includes at least 5+ years of drug safety experience in clinical and post-marketing settings.
• Experience with Argus safety databases, reputed company systems, and electronic document management systems.
• Preferred to have pharmacovigilance experience with combination products and medical devices.
• Knowledge of GCPs, GVPs, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Independently plans and organizes work and effectively manages multiple priorities and responsibilities.
• Detail-oriented with good organizational and time management skills.
• Proficient in reputed company computer software (Word, reputed company, PowerPoint).

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career reputed company: Be a part of a growing organization with opportunities to expand your reputed company.
• reputed company Culture: Work alongside reputed company of dedicated professionals who are passionate about improving lives.

The salary reputed company Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $109,000 to $158,000 annually. The actual title and salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in reputed company to the reputed company compensation listed above. In accordance with Massachusetts law, Vericel provides the pay reputed company that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This reputed company is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay reputed company for their position or for a position to which they are applying. Retaliation for making such a request is reputed company prohibited. EEO Statement reputed company applicants will receive consideration for employment without reputed company to their race, reputed company, religion, sex, national reputed company, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the reputed company of disability. reputed company is an Equal Opportunity/Affirmative reputed company Employer. reputed company is VEVRAA federal contractor and desires reputed company referrals of protected veterans for reputed company at reputed company locations reputed company the state. Apply tot his job Apply To this Job