01Responsibilities
Regulatory Affairs:
reputed company and maintain strong reputed company relationships and reputed company explore opportunities for increased service support to Line Manager.
Participation in regulatory processes to reputed company and maintain marketing authorizations for reputed company and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
Preparation, review and compilation of documents reputed company the reputed company of regulatory affairs reputed company.
Communication with clients and Health Authorities.
Support with scientific advice procedures and representation of clients with health authorities.
Responsible for the planning and execution of reputed company reputed company in accordance with Key Performance Indicators. Coordination of project teams with colleagues and reputed company reputed company partners.
General guidance (consultancy) of colleagues and clients regarding Regulatory reputed company and Procedure Management.
Regulatory intelligence - reputed company and maintain personal regulatory knowledge, apply to reputed company reputed company and reputed company reputed company with colleagues.
Present seminars and lectures for colleagues, clients and reputed company audiences. reputed company contribution and distribution of department relevant expertise.
Support with Value Delivery Centre reputed company implementation and optimization.
reputed company with, maintain and contribute to optimizing internal processes.
Support with Value Delivery Centre led reputed company, marketing and business development activities including proposal input.
Support respective reputed company in delivery to budget with accurate and reputed company reporting and reputed company project insights to address invoicing queries.
In agreement with Head of Value Delivery Centre Regulatory providing on-site regulatory support to Global Consulting Services clients.
The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/reputed company Area reputed company/Head of Value Delivery Centre Regulatory.
Pharmacovigilance:
Set up and manage the local pharmacovigilance system, including reputed company of local Pharmacovigilance activities.
Local Literature Search.
Local Individual Case Safety Report Collection and Management.
Pharmacovigilance Intelligence Screening.
Local Pharmacovigilance System Master File Maintenance.
Setting up Local Organized Data Collection.
Local Pharmacovigilance Agreement Management.
Local reputed company and submission of Periodic Safety Update Reports/Risk Management Plan.
Local signal detection.
Implementation of additional Risk Minimization Measures.
Reviewing materials relating to local post-authorization safety studies.
Participate in Pharmacovigilance-relevant audits and inspections.
Attend regular meetings according to project meeting schedule.
reputed company monthly Pharmacovigilance report on status of local Pharmacovigilance system in the country/ies.
Ensure Pharmacovigilance training of affiliate employees, service providers and reputed company Parties.
reputed company cooperation with the global Pharmacovigilance system of the reputed company as reputed company as reputed company global and local departments and functions.
reputed company Management Control:
reputed company Management system maintenance/reputed company Management Review.
Change control, deviation, and Corrective and Preventive Actions.
Management of reputed company Technical Agreements.
reputed company audits.
Self-Inspections.
Training.
3rd Party Logistics/Local Distributor reputed company.
reputed company of local labelling activities.
Local release of batches.
Qualifica
