At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Sr. Pharmacovigilance Manager (Sr. PV Manager) to join our A-team (hybrid*/remote). As a Sr. PV Manager at Allucent, you are responsible for administering, maintaining and coordinating the logistical aspects of clinical trial and post-marketing pharmacovigilance activities to ensure accurate collection, database entry, review and reporting of safety data at Allucent as well as overseeing all operational pharmacovigilance activities.
In this role your key tasks will include:
- Create/maintain study-specific forms for collection of safety data (SAE forms, etc.)
- Document potential serious adverse event (SAE) information during intake of calls/email/fax
- Collect SAE forms from sites in cooperation with CRA(s)
- Review SAE forms received and determine if a follow-up query is required
- Contribute to the performance of initial safety review and triage of SAEs to determine seriousness, expectedness and priority, including the timeline for response
- Review and perform quality check of written safety narratives summarizing all relevant medical information for individual case safety reports
- Review and quality check of safety documents (Expedited Reports (CIOMs Forms), Annual Safety Reports (ASRs), etc.
- Contribute to the performance of coding review of data from clinical study databases using standardized medical dictionaries (such as MedDRA)
- Liaise with the data management department to obtain required safety data and to provide safety input when required
- Support Perform reconciliation of clinical and safety databases
- Collect and perform quality control of safety documents to be reported to regulatory authorities, ethical committees and sites.
- Submit safety documents to regulatory authorities and ethical committees according to regulatory requirements including the generation of safety letters
- Create/maintain study tracking logs for regulatory submissions
- File and archive safety documents
- Support of other medical affairs activities as required
- Contribute to the development and maintenance of Develop and maintain standard operating procedures (SOPs)
- Provide basic safety training to new staff safety training to staff and at Investigator Meetings
- Mentors Pharmacovigilance managers
- Contribute to the improvement of departmental processes
- Actively support staff learning & development within the company
- Draft and contribute as Subject Matter Expert (SME) in the field of Pharmacovigilance Manager activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Assure strong long-lasting relationships with (future) key accounts
- Contribute and take part in client evaluations, visits and bid defenses
- Contribute to other areas of business as required
Requirements
To be successful you will possess:
- Minimum 5 years of pharmacovigilance experience, including at least 1 year of line management
- Good knowledge of GDP, GCP, GVP, GDPR and HIPAA regulations Experience working in ArisG safety database required
- Fluency in medical terminology
- Understanding of medical records including laboratory results and procedures
- Experience with MedDRA and WHODrug coding is required
- Experience with submission of expedited safety reports to Eudravigilance
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required
- Excellent analytical & problem-solving skills
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
United States
