GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Post : Senior SERM Scientist
Job Description
Key Responsibilities
1. Scientific/Medical Knowledge PV Expertise
• Practical experience in and basic and emerging additional knowledge of pharmacovigilance and safety surveillance.
• Able to work more independently with limited supervision as required.
• May be assigned as responsible for safety monitoring and evaluation of assigned GSK products.
• Performs routine PV activities to include the review of ICSRs and monitoring and evaluation of assigned GSK products.
• Review literature articles for Safety topics of interest and detection of safety signals.
• Basic labelling knowledge and may participate in labelling team activities.
• Draft Aggregate Report safety sections and support addressing response to queries (RTQs).
• Perform Quality assurance of SERM deliverables - capable of management monitoring activities.
• Support LOCs to respond to local regulatory requirements.
• Support senior colleagues in process improvement initiatives within the global safety.
2. Cross-functional Matrix team leadership
• Proficient understanding of a matrix team and matrix team requirements.
• Self-awareness of impact on others in matrix teams; respectful and being receptive to feedback on self.
• Capable of assisting senior colleagues in preparation for and presentations in matrix team meetings. May prepare for and present in matrix team meetings.
• Contributes to the activities of Safety Review Teams.
• Mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Can explain knowledge and skills, and work in new situations."
• Builds working relationships and responds to the needs of line functions in the matrix in relation to safety issues.
3. Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
• Proficient writing and verbal communication skills - demonstrates clear and effective oral and written communication skills. can communicate ideas in business forums such as local and global team meetings. Can engage others in discussion points.
• Keeps manager/supervisor informed of progress and activities and escalates issues appropriately.
• Proactive communication e.g. active communication of ideas supports decision-making through provision of relevant information. Early capability to support a safety risk position. Growing confidence in communicating through multiple channels
Candidate Profile
Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred.
• Minimum 7-12yrs of Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Experience working in large matrix organizations
Additional Information
Experience : 7-12 yrs
Qualification : BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm.D
Location : Bengaluru
Industry Type : Medical and Clinical
Req ID : 402650
End Date : 15th September 2024
See All M.Sc Alerts M.Pharm Alerts Ph.D Alerts Bangalore Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
