Pharmacovigilance Manager

For more than 130 years, Boehringer Ingelheim has been committed to the research, development, and manufacturing of new medications with high therapeutic value for people and animals. As a family-owned pharmaceutical company, Boehringer Ingelheim is able to take a long-term view and invest heavily in research and development. We are proud of addressing some of the most challenging healthcare issues. Our vision – value through innovation – has always characterized our collaborative work, and is for us simultaneously a fundamental requirement and a driving force.  

 Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

 We are currently looking for Pharmacovigilance Manager

 Position overview

Ensures the establishment and maintenance of a local pharmacovigilance (PV) system to support patient's and clinical trial subject's safety and public health in the assigned territory of Ukraine. Fulfills compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.

Acts as local PV point of contact person (local QPPV) for the national Health Authority as legally required.

 Key responsibilities:

• PSMF maintaining.
• Management & execution of QPPV tasks including but not limited to RMP, SDEA, labelling updates, PSMF.
• ICSR processing, Aggregate Reports (DSUR/PSUR) management
• PV Quality and compliance insurance, 
• Audit/ inspections excellence.
• Devising and establishing of processes and procedures, CAPA management & process Improvement.
• Contract management.
• PV Vendors management.
• Supporting the implementation of RMP commitments in cooperation with the global PVWG and relevant local functions.
• Responsible for management of PV relevant information received locally.
• Implements activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations.
• Maintains appropriate PV knowledge to ensure that BI fully complies with PV-relevant regulations in the respective territory
• Contributes to benefit-risk assessment of BI product portfolio.
• Acts as the key expert for any PV-relevant topics and ensures proactive communication as appropriate.
• Represents the local PV point of contact for communication and interactions with Regulatory Authority in close cooperation with the respective PVWG chairperson.
• Gives PV input to local / Regional innovative drug development and marketing activities such as Compassionate Use Programs, Non Trial activities, Non-Interventional Studies in liaison with GPV functions.
• Regularly updates the local Leadership team about the performance of the local PV system and proactively escalates any issue.
• Ensures appropriate PV training of all BI staff, vendors, and those working on behalf of BI in the respective territory.
• Manages local Pharmacovigilance Agreements (PVAs) in cooperation with Global Partner Management.
• Contributes to the PV Quality system.

 Required qualification & background:

• Pharmaceutical or medical degree, Life-Science degree is acceptable.
• Over 5 years of leadership/management experience for LPVM with line management of a local PV team.
• Experience of working in a diverse fast pace environment.

 Required knowledge & skills:

 Excellent knowledge of relevant Pharmacovigilance regulations, legislation and GCP, technical knowledge of drug safety databases regarding submissions and safety information exchanges. 

• Demonstrated ability to multi-task, have structural, organizational, communication and prioritization skills, proactive and assertive attitude, balanced decision making.
• Ability to work independently and as part of a team
• Advanced English is a must. 

If this vacancy has drawn your attention, please, send you CV for consideration.