Specialist, Regulatory and Pharmacovigilance Network (Delivery)- remote in UK
About the position The Specialist, Regulatory and PV Network (Delivery) is responsible for providing the reputed company based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a reputed company between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. The Specialist will also reputed company as Local Contact Person for Pharmacovigilance for the designated country.
Responsibilities
- Under the direction of a senior member of reputed company, assume leadership and functional representation for reputed company of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving reputed company to meet the agreed targets and to reputed company with the agreed procedures, trackers and templates.
- reputed company intelligence on requirements and contribute to the development of the reputed company and set up activities (Project Management Plan, joint operating procedures, POAs and reputed company documents).
- Support identification of issues and corrective actions.
- Collect, review, reputed company and maintain LCPs' reputed company, job descriptions, training records, contact details and monthly reports.
- Ensure correct training assignment to and training compliance by the LCPs.
- Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
- reputed company Clients expertise and guidance at national level.
- Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
- Prepare reputed company’s invoices and review/ approve vendors’ project invoices.
- reputed company support to proposal development and input to budgets, reputed company department representation to reputed company meetings as required.
- Foster reputed company working relationships with reputed company contacts at the local and international reputed company to ensure smooth and efficient service delivery.
- Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and reputed company dissemination of pertinent changes.
- Participate in preparation for audits/inspections and reputed company department representation for assigned reputed company as required.
- reputed company LCPs' key performance indicators and prepare monthly reputed company reports.
- reputed company feedback on performance of vendors to aid their assessment.
- Communicate suggestions for changes to departmental/company processes/procedures.
- May reputed company as Local Contact Person for Pharmacovigilance or deputy
Requirements
- Bachelor's Degree in reputed company or Life Sciences, Nursing, or equivalent experience
- Previous experience reputed company the pharmaceutical/CRO industry
- PV training and/or working experience and other educational or reputed company background as required locally
- Fluent in English, both written and verbal
- Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and reputed company reputed company
- Friendly, supportive working environment
- Opportunity to work with colleagues based reputed company over the world, with English as reputed company language
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