Concordia International is the result of the acquisition by Concordia Healthcare Corp (now Concordia International Corp) of the AMCo group on 21 October 2015.The combined businesses are highly complementary to each other, with well established product portfolios, and provide a strong platform for future growth through acquisitions in line with its strategy to build a truly global pharmaceutical company.
Post : Drug Safety Executive
MAIN PURPOSE OF ROLE:
• Play an active role within the Global Drug Safety Team, accountable for coordinating all aspects of product and patient safety in line with local and global pharmacovigilance requirements including GPvP
• Active coordination of maintenance of product safety profiles and implementation of safety signals arising from risk-benefit evaluations
• Contribute towards compilation and implementation of various safety led variations
• Ensure continuous high compliance in PV
KEY RESULTS AREAS (Core functional areas required to perform the job):
(a) Achieving and maintaining Compliance Excellence
• Contribute to drug safety activities to support product safety reviews and clinical evaluations.
• Keeping abreast of changing PV requirements globally; within specific focus on Rest of World territories.
• Responsible for the coordination of PSMF for real time compliance and QPPV oversight.
• Contribute towards continued improvement of safety systems and processes.
• Completing safety related variations and maintenance of product information.
• Support the Medical affairs team on key projects related to global governance
• Involvement in pre and post action arising from PV audits and inspections.
• Actively coordinate with all the internal and external stakeholders with members of Medical Affairs, Regulatory Affairs and Quality departments towards processing all the submissions to the Competent Authorities on time for ensuring Pharmacovigilance and Regulatory Compliance.
• Provide input into Quality System as required
(b) Contributing to a high performing team
• Work closely within the Medical Affairs team to support allocated duties to high standards at all times
• Contribute towards business value adding activities and seek opportunities for improvement.
• Prepare detailed and accurate reports on activities planned or carried out on regular basis (including collecting metrics) and submit them to the Senior Manager, Pharmacovigilance
KEY RESPONSIBILITIES AND ACCOUNTABILITIES:
• Comply with Global PV regulations and Company procedures
• Work closely with the PV team to ensure compliance in line with the PSMF and any territory specific requirements.
• Proactively drive process improvement in Drug Safety and lead remedial actions and initiatives.
• Ensure PV systems are in line with industry standards.
Find more info on Next Page...
Subscribe to Pharmatutor Job Alerts by Email
PERFORMANCE STANDARDS:
• Compliance with GPvP requirements, demonstrated through inspections and audits
• Support to the business and provision of documentation within agreed timeframes
• Successful relationships with all internal partners
•Collaboratively facilitate close-out of internal and external inspection findings
Qualifications:
Life Sciences or Pharmacy degree
Post graduate qualification
Experience & Competences
0-1 years experience in Drug Safety
Scientific data analysis
Compliance tracking (e.g. PSMF, safety databases, CAPAs)
PV Knowledge of legislation in Rest of the World markets (e.g. Middle East, Latam)
Experience of working with 3rd party vendors/service providers
Knowledge & Skills
GPvP Regulations in EU
Ability to work with teams across different geographies and cultures
Collaborative approach
Innovative solution finding
Strategy setting and implementation
Influencing and negotiating
Excellent attention to detail
Project Management
Candidate Profile :
Self awareness, strategic mind-set, advanced communication skills, results driven, stakeholder centric focus at all times, team player and willing to take accountability
Additional Information:
Experience : 0-1 years
Qualification : degree in Pharmacy or Life Science
Location : Mumbai
Industry Type : Pharma
Functional Area : Drug Safety
Last date : 30th September, 2016
See All B.Pharm Alerts M.Pharm Alerts Mumbai Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
