Founded in Sweden, with its long tradition of industrial entrepreneurship, Bluefish Pharmaceuticals has become one of the most progressive generics pharmaceuticals companies. At Bluefish, we strive to make quality medicines accessible to more people. We create value in the full pharmaceutical value chain from developing to manufacturing and successfully marketing generic pharmaceuticals and we take pride in doing this in an innovative, responsible and cost-efficient way. Bluefish currently conducts operations in 19 countries in Europe and, over the next few years, will also expand outside Europe with the aim of becoming a global player.
Post: General Manager Pharmacovigilance
Overall responsibility of Pharmacovigilance operations from Bangalore office.
Liaise between the PV team from Bangalore with the QPPV & Deputy QPPV in head office and assure the QPPV has an overview of the entire PV activities.
Assist EU QPPV and Deputy QPPV on all the PV requirements.
Develop and train the personnel within PV team. Identify training needs for the team.
Inter functional interaction where applicable (Regulatory Affairs, Quality Assurance, Research and Development, Sales and Marketing, etc.) for PV related activities.
Review and approval of all critical reports within PV
Responsible for the implementation of PV SOP system
Responsible for PV inspection by the competent authorities and internal audit within company
Implementation of the current EU guideline and legislation within the PV system
Responsible for assisting QP PV to respond to the PV queries received from the Competent Authorities.
Ensure timely submission of safety communication to the competent authorities and target audience.
Monitor compliance metrics and investigate opportunity for process improvements
Review the safety profile of company products including: Periodic Safety Update Report (PSUR), Risk Management Plan (RMP) updates and signal detection activities
Develop and execute strategic plans for improving the quality of PV process in areas impacted by European and worldwide Pharmacovigilance regulations
Experiance 10-15 years
UG - Any Graduate - Any Specialization, MBBS - Medicine, Other Graduate, B.Pharma - Pharmacy
PG - Any Postgraduate - Any Specialization, M.Pharma - Pharmacy
Handling and management of Pharmacovigilance team for EU.
Experienced in the current GVP and involved in implementation of the new guidance
Capabilities to provide Leadership and vision for PV system and organization.
Handling critical Pharmacovigilance systems like PSMF, RMP, Signal management, Safety data base, PSURs etc.
Experienced in communicating with the Competent/Regulatory agencies on all PV related matters.
Showcasing good documentation skill to write, review & approve corporate SOPs and other relevant report within PV system
Qualification: B.Pharm, M.Pharm, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 30th Dec., 2013
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