Mgr Drug Safety (BB-DE16B)
Found in: Neuvoo CN
Entry of safety data onto adverse event tracking systemsReview of adverse events for completeness, accuracy and appropriateness for expedited reportingWrite patient narrativesCode adverse events accurately using MedDRADetermine expectedness/listedness against appropriate labelIdentifies clinically significant information missing from initial reports and ensures its collectionEnsure cases receive appropriate medical reviewPrepare follow-up correspondence consulting with the medical staff accordinglyEnsure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelinesReporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
• 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.
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
• Participate in Covance project teams and provide training about adverse event reporting to non-PSS personnel.
• Train new employees overall in pharamcovigilance and regulatory reporting.
• 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.
• Maintenance of files regarding adverse event reporting requirements in assigned countries.
• Assist with the generation and review of SOPs, Work Instructions etc.
• Responsible for SOP implementation within assigned team.
• Assist in developing Operational metrics measuring PSS’ overall performance.
• Assist with the recruitment of new staff to PSS.
• Build and maintain good PSS relationships across functional units.
• Demonstrate role specific Competencies on consistent basis.
• Demonstrate company Values on consistent basis.
• Financial authority as it relates to projects.
• Any other duties as assigned by management.
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.
• 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.
calendar_today1 day ago
work Covance Inc