Additional InformationLocation: England Sector: Pharmacovigilance Salary: £72000 - £80000 per annum + good benefits and package Position Type: Permanent Ref: VR/02755 Contact InformationAmber Burns 01273 727 930 |
Safety Science LeaderThe Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Part of the accountability is exerted by bringing the safety topics to the Clinical Team and when appropriate to the Life Cycle Team in order to ensure that adequate measures based on safety findings are taken and also implement the CIOMS 6 recommendation of a cross-functional team including preclinical, pharmacology, clinical development, strategic marketing, biometrics. With the CSL and GRL, they focus on characterising the benefit/risk of the product and ensure the safety and longevity of their products throughout their development and commercial lifecycle. The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for the safety component of the Early Development Plan/IDCP, study protocols and reports, data evaluation and clinical NDA / BLA preparation as well as various periodic safety reports. in order to optimize the benefit/risk profile and communicate it clearly. You will be; Minimum: Physician who would be eligible for medical practice in EU or in US and a significant period of time in clinical practice Strongly desired: MD and PhD Post doctorate experience in a speciality like internal medicine, pediatrics, geriatrics is highly valued Experience, Skills, Knowledge: ·Previous experience in the pharmaceutical industry (preferably including safety but may be in clinical development or medical affairs). ·Significant experience of drug development including the evaluation and interpretation of scientific and clinical data. ·Demonstrated knowledge of Safety Science across a breadth of therapeutic areas particularly in relation to issue management and signal detection and evaluation. ·Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations ·Proven experience in proactively leading a team of individuals located across a number of sites and in leading them to optimise their performance and contribution. Proven ability to coach and develop people. ·Demonstrated experience of proactively driving a variety of tasks and projects and delegating to a team. Able to manage budget and time lines. ·Strong written and verbal communication skills to a variety of levels and teams, internally and externally. Demonstrated persuasion, influencing and negotiation skills. ·Ability to operate objectively and independently as a leader and as a member of a team, as required ·Ability to interact effectively in a multifunctional and multicultural team setting (Safety team, Clinical team, Life Cycle Team) ·Ability to interact with Health Authorities as the primary contact person for safety aspects in face to face meetings Please call Amber Burns on 44 1273 727 930 to discuss this more opportunities or email amber@stelfoxuk.com Apply |