We are currently looking for a Safety Lead to join a leading Biopharmaceutical company. As the Safety Lead you will be responsible for Global oversight of safety risk management activities for various therapeutic areas.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Safety Lead will be varied however the key duties and responsibilities are as follows:
1. You will provide strategic safety leadership for various, assigned, products, across various cross-functional teams and governing bodies. This will include the life-cycle product team, labelling team, global labelling committee and more.
2. You will lead a cross-functional Benefit Risk Team, ensuring that all relevant data is assessed, acted upon and integrated into the benefit risk assessment.
3. As the Safety Lead, you will provide oversight of safety risk management activities for assigned products, including clinical safety, signal detection / management, aggregate reports, risk mitigation, risk communication and risk management.
To be successful in your application to this exciting opportunity as the Safety Lead we are looking to identify the following on your profile and past history:
1. Proven industry experience, managing Case files, medical reviews, safety risk management.
2. Proven industry experience and understanding of relevant regulations and proven evidence of effective delivery of high quality documents. As well as relevant concepts in data management and systems.
3. The technical skills and capabilities to author and contribute to large complex documents and the knowledge of concepts in health care, human biology, data management and systems, pharmacovigilance, drug development and statistics.
Key Words: PV, Pharmacovigilance, Case Management, Risk Management, Safety, Post Approval, Data Management, Quality, Medical, Pharmacist, Project Management, Therapeutic,
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Chris Carey
- Phone: 0203 910 2980
- Reference: J5634049
- Posted: 17th November 2020
- Expires: 15th December 2020