Clinipace Worldwide is a different kind of CRO, where people are the backbone of our technology-amplified processes. We are a global full-service digital Clinical Research Organization (dCRO) and one of the fastest growing companies in America. Clinipace currently has a global footprint of 31 offices in 25 countries. Our proprietary technology combined with an innovative service model transforms drug and medical device development. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development. Our associates are passionate about their lives and bring that same passion to their work at Clinipace Worldwide.
Post : Pharmacovigilance Specialist Senior
Job Duties and Responsibilities:
- Receipt of incoming case information via project specific mailbox/fax daily OR via an autogenerated SAE notification email from TEMPO and/or designated EDC system per project requirements.
- Tracking and triage of case information for processing
- Prioritize incoming AE/SAE/ER information for further processing and confirm receipt, as required.
- Identify potential 7-Day and 15-Day Alerts
- Prepares disposition email to notify client of case assessment details (confirmation of serious criteria, expectedness and causal association) as required.
- Assumes case ownership responsibility for non serious, spontaneous and or serious clinical trial domestic and foreign cases as applicable.
- Consults with multiple stakeholders (e.g. the sponsor / medical monitor / pharmacovigilance physician) to decide on action and/or additional steps to provide complete narratives to the sponsor.
- Conduct active follow-up for clarification and missing case details
- Handling of safety information according to given processes and procedures, by CPWW and/or client SOPs, WPs and Guidelines
- Enter initial and follow up information in the CPWW safety database or clients database, according to project requirements, as required.
- Review and/or perform coding for all required medical/drug terms according to given coding dictionaries and applicable coding guidelines
- Develop case narratives, per project specific template.
- Unblind treatment codes in studies, if applicable
- Create safety line listings as required
- Provides final narrative and/or CIOMS I form /MedWatch form to the client after review by the MM/ SPV
- Perform/coordinate expedited reporting according to project requirements
- Possess general working knowledge of local and international PV regulatory frame work
- Supervising of less experienced PV Pharmacovigilance Specialists (Junior and Regular) in the performance of tasks.
Job Requirements:
Additonal tasks and responsibilities depending on the level of experience:
- Data retrieval from safety databases or EDC system
- Support the work of Pharmacovigilance by generating ad hoc adverse event reports (data retrieval) according to input or by request of Safety Physician
- Generate validated ad hoc reports as well as periodic reports from safety database as requested
- Expert for coding (MedDRA and other coding dictionaries)
- Expert for Argus Safety (System Owner),- Serves as intermediary between Users and IT
- Maintenance activities for the User Manual of the Argus Safety Database
- Assistance in Proposal calculation and in preparing requests for information (RFI)
- Participate in regulatory audits and inspections in cooperation with QA, as needed.
- Participate and present in bid defense, client, team or investigator meetings (as applicable)
- Review and preparation of draft working procedures and training materials, providing input to SOPs
- Clinical Event Committee (CEC) – support, triage cases for adjudicable events, prepare packets for committee review, as applicable.
- Serve as Responsible Person for EudraVigilance (RP-EV)
- Registering of company headquarter, affiliates, third party providers and users
- Assistance in preparing PSURs, DSURs, RMPs, signal management documents, and others, as applicable (e.g. review of periodic listings for detection of potential safety signals, Quality control of documents )
Candidate Profile :
Education:
Degree in life science or nursing/pharmacy qualification or other advanced or equivalent appropriate healthcare or pharmaceutical industry experience or education, e.g. laboratory experience.
Medical Documentalist, Medical Documentation Assistant, Nurse with extensive clinical experience or life science degree (e.g. natural scientist with a degree in biology, pharmaceutical medicine of similar speciality) preferred.
Experience:
At least to 3- 4 years experience in the tasks and responsibilities performed by a Regular (PVS).
Advanced proficiency in use of safety database and/or EDC system (per client directive).
Advanced knowledge of medical terminology.
Deep understanding of drug development and safety data processing and working processes.
Advanced knowledge of international PV relevant rules and regulations (for clinical trial, post-marketing surveillance and medical devices)
Experience in Project Management
Other tasks as required.
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Skills/Competencies:
- General knowledge of drug therapy, disease states, clinical research.
- Applies working knowledge of pharmacvigilance processes and requirements to complex situations.
- Advanced medical knowledge, ability to analyze, draw conclusions, and formulate recommendations related to potential safety issues.
- Excellent computer knowledge. Use of MS office applications to a competent standard for Word, Excel, and PowerPoint.
- Sound working knowledge of regulatory reporting requirements and international regulations (EU, US ,Japan and Asia).
- Experience with team leading roles or comparable leadership functions.
- Willingness to provide guidance and training to less experienced staff.
- Willingness for continous on the job training and qualitfications measures.
- Basic understanding of financial aspects of projects.
- Practices professionalism and integrity in all actions – demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
- Works through conflict and drives productive resolution.
Capabilities:
- Ability to prepare draft working procedures, templates and/or training material
- Ability to review and provide input for SOPs, working procedures, and guidelines
- Ability to review and give input to Draft Safety Safety Management Plan (SMP)
- Ability to provide quality control (QC) of scheduled expedited reports within safety database and/or designated EDC system (e.g. TEMPO) as applicable.
- Ability to process or retrieve safety information, initating searches and/ or generate reports from the safety database or designated EDC system (e.g.TEMPO), as applicable.
- Ability to maintain and protect client, patient and corporate confidentiality.
- Ability to work in an environment of rapidly changing priorities and manage multiple client projects.
- Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
- Ability to organize and manage work to meet strict timelines.
- Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
- Ability to work independently with high reliability and a high sense of responsibility.
- Ability to work as a member of a team and possession of confident communication skills both written and verbal.
- Ability to communicate in English (both written and verbal) .
- Ability to work with careful attention to details.
- Up to 10 % travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
Additional Information:
Experience: 3-4 years
Qualification: Graduate with a life science / Pharmacy
Location: Trivandrum, India
Industry Type: Pharma
Functional Area: Pharmacovigilance
Last date : 15th May, 2017
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