Deputy to PV Head

We are hiring a Deputy to Pharmacovigilance Head who will support the PV Head in Johannesburg . It is a half day – permanent position.

Pharmacovigilance Accountabilities (Deputy to LPVM):

• Assist the local Pharmacovigilance Manager (LPVM) in maintaining a compliant PV system.

• Ensuring the compliance with respective legislation at all times for all relevant countries.

• Implementation of company global and local procedures.

• Assume PV responsibilities for local activities for Clinical Trials (CTs), Investigator Initiated Studies (IIS), Non-Interventional Studies, Compassionate Use Programs / Early Access Programs, Non-Trial Activities and Post Authorization Safety Studies.

• Act as a deputy in the absence of Qualified Person for Pharmacovigilance (LPVM) to local Authorities, whenever required by local regulations
• Ensure local safety data collection and safety reporting, including receipt, processing, distribution, tracking, archiving and follow-up of safety information locally, according to the company procedures and regulations.
• Entering data into respective databases ensuring high accuracy and attention to detail.
• Reporting of relevant individual case safety reports and safety periodic reports to Regulatory Authorities and Ethic Committees, according to local requirements.

• Screening of local literature for adverse event information.

• Review of local customer related screening system results for adverse event information.
• Reconciliation with key partners, e.g. Product Complaints and Medical Information.

• Monitoring and testing of sponsored and company owned websites.

• Handling of regulatory safety requests and any other safety inquiries/issues in close collaboration with local management, ROPU and Regional PV Heads.

• Assist in the reporting and investigation of non-compliances

• Contribute to corrective and preventative action preparation and follow-up processes, whenever applicable
• Assist with Local inspection readiness
• Assist with handling of local PV audits

• Assist with the contribution as appropriate at a local level for implementation and monitoring of risk minimization measures for all products

Minimum Education/Degree Requirements

Required Capabilities (Skills, Experience, Competencies)

• Minimum 4 years of experience in pharmacovigiliance in the pharmaceutical industry
• Customer approach with high business understanding
• Result orientation and managing ambiguity in difficult situation
• Creativity on finding solutions with ‘can do’ approach
• Setting direction and leading change
• Managing people; attracting and developing talents
• Time management

Boehringer Ingelheim is an equal opportunities employer. We value your passion to discover, invent, simplify and build. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief. We are required by law to verify your ability to work lawfully in South Africa. Boehringer Ingelheim requires that you submit a copy of either your identity document or your passport and any applicable work permit if you are a foreign national, along with an updated curriculum vitae. Boehringer Ingelheim South Africa (Pty) is strongly committed to diversity within its community and Employment Equity within the workplace, and the further diversification of ideas. In this regard, the relevant laws and principles associated with Employment Equity will be considered when appointing potential candidates.