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Patient Safety Manager – Pharmaceutical

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A Multinational Pharmaceutical company has an opportunity for an experienced Patient Safety Manager to lead pharmacovigilance activities to ensure patient safety.

 

Job Description   Lead pharmacovigilance activities in the company affiliate, in the context of the Pharmacovigilance System, patient safety operating model, and associated quality system, to ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment.

Influence the affiliate organization as a key member of the affiliate organization with high visibility, to promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities. Advocate for the needs of the affiliate at regional and global level to ensure that safety requirements are well supported

Ensure the seamless flow of safety relevant information, within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the the company patient safety operating model.

Maintain awareness on safety profiles of The company products and provide safety expertise and support for all marketed and investigational products – drugs and medical devices – to other functions in the affiliate, to ensure their safe and effective use, specifically through implementation of risk management plans and risk minimization measures.

Establish or participate in oversight mechanisms on safety activities, specifically those outsourced to vendors on behalf of the affiliate (local activities, such as in patient-oriented programs as well as core safety activities, and core safety activities, such as case handling and periodic report generation), to ensure that they are well executed and satisfy quality and compliance expectations.

Participate in the maintenance of the local quality management system, including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors.

MAIN RESPONSIBILITIES

1. Leadership
2. Communication flow
3. Single point of contact [and 24hr availability]
4. Management of Safety Information
a. Management of Adverse Events
b. Product Complaints management
c. Management of Periodic reports
d. Management of Local Literature
5. The company’s product safety profiles and related actions
a. Health Authority Requests (and other externally generated signals)
b. Awareness of the company’s product safety profiles
c. Risk Management
d. Ad hoc Safety Measures
6. QMS and supporting processes
a. Local Procedures
b. Trainings
c. Records management
d. Compliance Management
e. Audits and Inspections
f. Deviation and CAPA
g. PSMF/PSSF
h. PV Agreements
i. Regulatory Intelligence
j. BCP
k. IT systems
l. Local 24hr accessibility
7. Governance

Commitment to Diversity & Inclusion:           We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements          Education (minimum/desirable): Health Care Sciences

Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.

Languages:
• Certified level of written and spoken English.
• Good working knowledge of local language.
• Knowledge of other languages (desirable).

Experience/Professional Requirement:
• Minimum 7 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
• Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.
• Extensive knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
• Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
• Experience in PV audits and inspections.
• Demonstrated track record to successfully lead/work in interdisciplinary global, and prioritizing activities simultaneously on multiple projects.
• Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members.
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational and interpersonal skills.
• Computer/IT systems literacy.

 

Send your updated CV  to Vicki  at vicki@medicalcareers.co.za

Successful applicants will be contacted within 10 days.

 

Only candidates can apply for this job.
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