Medical Director, Safety Evaluation & Risk Management (SERM)
Proclinical is currently recruiting for a Medical Director of Safety Evaluation and Risk Management (SERM) with a pharmaceutical company located in Upper Providence, PA. Successful candidate will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level.
- Deliver strategic solutions and lead the implementation for key organizational/process changes ensuring that the company can comply with pharmacovigilance regulations worldwide.
- Develop strategy and lead the implementation of core business activities (e.g. Communications, Information Management, Training), seeking endorsement from the Central Safety Leadership team; provide ongoing, thoughtful program management and change management support to ensure delivery against a strategic agenda.
- Lead the review and re-design of critical business processes; deliver solutions that align across business units; develop and lead training / change management activities.
- Provide specific subject matter expertise on relevant business processes to ensure regulatory compliance and appropriate management of risk across the company (to include authoring process documents, adhering with evolving regulatory requirements, delivery of training and the proactive identification of potential compliance risks).
- Secretariat to Central Safety governance boards/leadership teams as appropriate; ensure appropriate/timely agendas/minutes (to include action tracking) based on input from stakeholders; provision of appropriate project management leadership.
- Project management support for the business change initiatives/process updates to include driving the development and tracking of business plans (including objective setting, Key performance Indicators, benefits tracking).
- Line manage scientific/technical associate staff who support specific business activities including provision of metrics, information management, communication and website related deliverable (as needed).
Skills and Requirements:
- Medical degree with minimum 3 years in clinical practice.
- Advanced Degree Life Sciences or Pharmacovigilance preferred.
- Oncology or immunology experience.
- Professional certification in Project management preferred.
- Experience with Pharmacovigilance processes and global Pharmacovigilance regulations.
- Prior experience managing multiple strategy formulation and change projects.
- Ability to effectively influence key stakeholders at all levels of the organization.
- Ability to see the big picture and make informed recommendations.
- Hands-on and self-reliant; able to work independently with diligent attention to detail.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Yannick Dada at (+1) 646-741-8433 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.