Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.
Post : Manager Drug Safety
Job Summary
The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
• Line manage PV&DSS staff including performance reviews, human resource issues, and assist Senior PV&DSS Management in assigning resources to projects.
• Manage the overall PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post mrketing setting (i.e., unsolicited reports) for specified projects.
• Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company's Health & Safety Manual.
Job Duties
• 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.).
• Escalate issues to Senior Management as needed
• Ability to proactively problem solve
• Participate in department improvement initiatives (identification, implementation)
• Assist with development and continual improvement of departmental training curriculum
• Provide input on junior staff development
• Participate in interview process for new/replacement staff
• Act as a support person in the preparation of study-specific Safety Monitoring Plans for Managers, DSPMs
• Assist in mentoring junior PV&DSS Managers and DSPMs within the team
• Take lead on ad hoc strategic initiatives
• May lead or assist with the management of PV&DSS concerning project allocation and
• Act as primary team lead for 1-2 projects
• Oversee individuals who manage receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but not limited to:
• Entry of safety data onto adverse event tracking systems
• review of adverse events for completeness, accuracy and appropriateness for expedited reporting
• write patient narratives
• code adverse events accurately using MedDRA
• determine expectedness/listedness against appropriate label
• identifies clinically significant information missing from initial reports and ensures its collection
• ensure cases receive appropriate medical review
• prepare follow-up correspondence consulting with the medical staff accordingly
• ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
• reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
• Oversee the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to:
• review and update adverse event databases and tracking systems
• review of adverse events for completeness, accuracy and appropriateness for ESR
• review of patient narratives
• review the coding of adverse events
• review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
• Oversee individuals who manage triage, distribution checklist and quality review of all ESRs 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 reporting
• 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 management of EudraVigilance activities for assigned projects.
• Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
• Contribute to the generation and review of Time and Cost Estimates for PV&DSS business.
• Ensure that PV&DSS teams 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.
• Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
• Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.
• Consistently responsible for assisting with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards.
• Assist in the co-ordination of endpoint committees.
• Participate and demonstrate leadership on projects which enhance team and/or division This includes acting as lead contact for projects including global projects ensuring communication and processes are harmonized.
• Prepare the team for client audits and regulatory inspections; and where applicable participate in audits, either by the client or a regulatory agency.
• Consistently contributes to solving technical and/or operational problems of program/project
• 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:
• Serious Adverse Event reporting at investigator meetings.
• Client capabilities meetings, as appropriate
• "Department Overview" to internal clients
• Attend client meetings and liaise with clients where appropriate.
• Take a lead in strategic interactions and partnerships with clients
• Ensure compliant safety reporting in accordance with international repotting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for ensuring the cascading of 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 nonPV&DSS personnel.
• Train and mentor new employees overall in pharmacovigilance and regulatory reporting.
• Maintains a comprehensive understanding of Covance PV&DSS' SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and
• Possess knowledge of all other CDS procedural documents that impact PV&DSS.
• Oversee the maintenance of files regarding adverse event reporting requirements in assigned
• Lead the generation and review of SOPs, Work Instructions etc.
• Responsible for SOP implementation within assigned team.
• Assist in developing Operational metrics measuring PV&DSS' overall performance.
• Manage the recruitment of new staff to PV&DSS.
• Build and maintain good PV&DSS 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.
Candidate Profile
- Level of education required ( or experience level which may be substituted for level of education)
- Professional designation/certification/licenses required
- Non-degree +10 years safety experience
- Associate degree +8-9 years safety experience*
- Associate degree RN=7-8 years safety experience*
- BS/BA +6-7years safety experience*
- MS/MA +5-6 years relevant experience**(4-5years safety experience)
- PharmD+3-4 years relevant experience ** (2-3 years safety experience)
- For Pharm D, 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 naratives, 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
• At least 4 years line management and/or project management experience.
• Industry experience of which 6 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 PV&DSS Management's team
• Strong leadership capabilities
• Excellent communication
• Overall departmnetal resource
• Client service focus
• Ability to multitask and priortize
• 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 related to clinical safety documentation
• Knowledge of world wide regulatory requirements and reporting of adverse event for both marketed and investigational products
• Knowledge of Medical Device Reporting desirable
• Knowledge of agggregate reporting
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial
• Financially intuitive
• Profiecient knowledge of ICH Guidelines
Additional Information
Experience : 2-5+ years
Qualification : Pharm.D, Pharm.D, M.Sc, B.Sc,
Location : Bangalore
Industry Type : Pharma
Functional Area : Drug Safety
End Date : 30th November, 2018
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