A Global Medical Organization is seeking a Local Medical Safety Specialist to work on a 1 (one) Year Contract. The incumbent will ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs. Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
Benefit Risk Management
Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Local Safety Officer (LSO) if applicable
Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate
Provide Risk Management Plan status updates
Prepare Local RMPs/ Addendums etc (if performed by IPV)
Involvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required
Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety as required
Involvement in DHPCs management, submit and track DHPCs to RAs (Regulatory Authority)/HCPs (if performed by IPV)
Involvement in local safety signal detection, if applicable
Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, Research Related Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations
Perform concept and protocol review related to data generation activities - clinical and post-authorization studies (for Pharma in RECAP) and Local Safety Monitoring Plan (SMP)
Provide support to HUB for local RRA
Medical/ pharmaceutical assessment of local individual cases when requested in partnership with global teams if applicable
Undertake appropriate actions such as site visits for special interest cases as requested by LSO
Support to implement CCDS into local label (SmPC, patient Leaflet etc) when required
PV-Safety training support
PV contract management
Local Safety compliance (PV and non-medicinal product safety)
Pharmacovigilance and Vigilance Service Provision
Pharma: Internal exchange with the International Medical Safety Leader, GMO functions, Medical Affairs, RRA Hub, Business Quality Assurance and Local Marketing organization. Consumer: Internal exchange with Global Strategic Insights, Consumer Science, HIVE/HUB teams for Research Related Activities; with Business Quality Assurance, Local Marketing and Digital Marketing for product oversight and promotional activities, Regional and global MSOs; External exchange with third parties, e.g., within the scope of co-promotion agreements. Exchange with Regulatory Authorities if needed. Exchange with Local Industry Associations and Patient Advocacy groups.
EDUCATION & EXPERIENCE REQUIREMENTS:
Essential Knowledge & Skills Scientific/ life-science background, medicinal knowledge preferred; proficiency in medical terminology (local languages). Ability to manage multiple critical issues. Computer literate with basic knowledge of GMS database systems. Awareness of and familiarity with industry principles of drug development and pharmacology Proficiency in global and local SOPs Good verbal and written communication skills, fluency in local language(s) and English language required. Ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships within the organisation and with authorities. Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety. Experience Scientific study and experience in pharmaceutical regulations and R&D processes. Pharmaceutical industry experience including a PV responsibility role required.
6 to 8 years experience
Please Note Only suitable candidates will be contacted
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