Medical Director Risk Management

Há 3 dias

Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiro

Overview
Syneos Health, Inc. is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

About Us

We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Responsibilities

The Medical Director Risk Management will provide strategic expertise to product teams and drive the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety.
Collaborate in the development of innovative methods to develop the next generation for Risk Management Sponsor team.

  • Provide expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products.
  • Recommends appropriate risk mitigation options for drug-related safety issues, taking into account the benefit-risk profile of the drug.
  • Reviews RMP assessment reports to determine if modifications are required.
  • Supports with strategic guidance for risk management planning, considering local regulatory requirements and product specific risk profile.
  • Acts as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP.
Requirements

To be considered for this role, you must have:

  • B.S., M.S. in health science.
  • Advanced degree preferred (Pharm.D, or Ph.D, or equivalents).
  • Senior Manager level - Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a focus on drug safety risk management.
  • Director level - Minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a focus on drug safety risk management.
  • Knowledge of global safety regulations and guidelines.
  • Demonstrated experience in global drug safety risk management planning activities and generating RMPs.
About Syneos Health

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.

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