Hobson Prior are currently seeking an Affiliate Safety Officer to join a global biopharmaceutical company who focus on developing and marketing pioneering drugs for high unmet medical needs. This role reports into the Commercial Director.
- Represent as the Affiliate Safety Officer.
- Ensure safety reporting requirements as set out in company policies and SOPs are met and appropriately managed at all times and through all project planning, materials development and contracting of external vendors.
- Uphold strong working knowledge of local regulatory requirements relevant to pharmacovigilance as well as worldwide requirements.
- Ensure local reporting and handling of adverse events according to the relevant SOPs, including daily monitoring cover.
- Deliver Induction and annual PV training.
- Sustain a close working relationship with Global Drug Safety and EU QPPV and keep them up-to-date on new local regulations/requirements.
- Supports the affiliate and the Global Organisation during Regulatory audits from the Competent Authorities.
- Respond to all medical information queries from both internal and external stakeholders with the most up-to-date information and within identified timeframes.
- Communicate with the Global Medical Information Team in creating and regularly updating standard reply letters.
- Capability to understand and interpret complex scientific concepts and communicate findings to customers.
- Demonstrated the ability to work effectively as part of a multi-functional team.
- Strong organizational and problem-solving skills with the ability to work under pressure and meet tight deadlines.
- Excellent written and verbal communication skills including the ability to make and deliver engaging presentations.
- Strong attention to detail.
- UK registered pharmacist (preferred) / Life science background.
- Minimum of 3 years' experience of working in the UK pharmaceutical industry.
- Excellent experience of medical information processes, the ABPI and IPHA Code of Practice, MHRA Blue Book and other relevant regulations.
- Previous experience with communicating relevant Global Head Office teams to ensure smooth flow of role-relevant information.
- Previous experience reporting of adverse events at the country level.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.