The Manager, Drug Safety will manage a team of Drug Safety Associates. This is a home-based position in the US.
- Responsible for the line-management of individuals within a team as well as a project team.
- Manage direct reports to ensure staff training records are up to date.
- Responsible for managing performance reviews and issues of direct reports.
- May manage individuals across multiple teams and will take on responsibility for cross department projects.
- Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
- May lead or assist with the management of PSS concerning project allocation and resourcing.
- General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
- General oversight for the management and processing of expeditable safety reports (ESRs).
- Complete triage, distribution checklist and quality review of all ESR for assigned projects.
- Execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
- Maintain awareness of Covance's safety database conventions and system functionality.
- Maintain awareness of other client safety database conventions and functionality.
- May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate .
- Responsible for the timely preparation and review of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
- Work closely with the clinical operations and project management groups to ensure all drug safety activities are performed according to the regulatory and contractual requirements.
- Prepare and participate in audits, either by the client or a regulatory agency.
- Consistently proposes and executes innovative solutions which influence program/project direction.
- Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Effectively draft/modify and deliver safety presentations.
- Attend client meetings and liaise with clients where appropriate.
- Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
- Maintains a comprehensive understanding of Covance PSS' SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of all other CDS procedural documents that impact PSS.
- Assist with the generation and review of SOPs, Work Instructions etc.
- Assist in developing Operational metrics measuring PSS' overall performance.
- Assist with the recruitment of new staff to PSS.
Level of education required (or experience level which may be substituted for level of education).
Professional designations/certifications/licenses required
- Non-degree + 6-7 yrs safety experience*
- Associate degree + 5-6 yrs safety experience*
- Associate degree RN + 5-6 yrs safety experience*
- BS/BA + 4-5 yrs safety experience*
- MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience)
- PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience)
For PharmD, a one-year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.Experience:
- Must have experience in safety operations for BOTH clinical trial and post-market PV.
- At least 2 years line management and/or project management experience.
- Industry experience of which 4 years is relevant to pharmacovigilance/drug safety knowledge.
- Good verbal, written and presentation skills.
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- Work collaboratively with PSS Management's team
- Leadership capabilities
- Good Communication
- High degree of accuracy with attention to detail.
- Ensure client and global regulatory compliance.
- Will present and share useful business information across departments and functions
- Anticipate/identify problems and takes appropriate action to correct.
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
- Knowledge of Medical Device Reporting desirable
- Knowledge of aggregate reporting desirable
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Financially intuitive
- Knowledge of ICH guidelines.
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
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