Manager Medical Safety & Pharmacovigilance – Woburn, MA
The Manager Drug Safety & Pharmacovigilance will be involved with global pre- and post-marketing drug safety and pharmacovigilance activities and will be responsible for assuring the processing and reporting of safety reports in compliance with SOP’s, guidelines and worldwide pharmacovigilance regulations. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors and corporate partners. Reports to: Head, Medical Safety & Pharmacovigilance
- Oversight of contracted safety vendors to ensure timeliness and excellence of safety functions and deliverables in alignment with Master Service Agreement and applicable Statement of Work.
- Manages safety case processing including triage, initial review and routing for safety medical review and maintains department tracker for received cases
- Ensures notification of relevant functions including safety Medical Reviewer, Regulatory and Clinical representatives for timely processing of safety reports in accordance with SOPs and regulatory requirements
- Performs standard quality and completeness check of data entry for all serious adverse event reports and other safety documents
- Ensures adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events
- Subject Matter Expert in the development and maintenance of PV plans including safety management plans, regulatory reporting plans, and SAE reconciliation.
- Leads and/or maintains safety department project management activities including organize safety team meetings, maintain safety project timelines, take meeting minutes, archive safety-related documents, maintain team shared work folders and documents
- Supports the planning and preparation of aggregate safety reports such as the Development Safety Update Report, Periodic Benefit Risk Evaluation Report, periodic line listings, safety assessments, ad-hoc analyses, as assigned
- Supports signal detection and risk management activities including periodic aggregate reviews of clinical trial data and serious adverse events from PV vendor
- Safety team member, works with Safety Medical Reviewer and interfaces with Medical Monitor, Biostatistics, Data Management, Clinical Trial Managers to ensure communication of safety related documents, completion of timely reviews, updating of core safety information and risk management plans, and maintenance of expectedness assessments for ICSR reporting
- Performs safety activities including SAE reconciliations, vendor reconciliations, oversight of submission compliance, and case QC, and case closure
- Oversight of safety data exchange with corporate partners to ensure compliance with contracts and agreements related to safety case processing and reporting
- Maintains departmental and pharmacovigilance documentation in an audit-ready state.
- Participates in inspections and audits including inspection readiness activities
- Supports root cause analysis and investigation of issues related to case processing/safety operations and corrective and preventive action (CAPA) measures following review of root cause analysis
- Supports department initiatives on ad hoc basis
- Assists in creation of PV related training materials, authoring of PV SOPs and work instructions.
- Reviews MedDRA/WHO Drug coding as requested
- Other responsibilities as assigned
Some travel may be required (<10%)
Qualifications Education and Professional Experience:
- Bachelor’s degree required in a health care discipline (RN, PharmD, PA are preferred)
- A minimum 5+ years of pharmacovigilance experience at a biotech, pharmaceutical, or CRO company, with at least 4 years hands on experience in adverse event case management is required. • Safety case processing experience is required.
- Job title based on experience.
Skills and Abilities:
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
- Knowledge of MedDRA dictionary relevant to AE/SAE coding
- Experience with software-based drug safety systems (ARIS-G and/or ARGUS experience is required)
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies.
- Must be able to work on multiple projects simultaneously.
- Ability to prioritize work without much support.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Proficient in Microsoft Office (Outlook, Word, Excel and Power Point)
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
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