Merck & Co., Inc
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its
legacy for over a century
. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the general direction of the VP Clinical Safety and Risk Management, the Associate Vice President as the CSRM Therapeutic Area Lead is a highly experienced safety physician responsible for the oversight of the overall clinical safety assessment and risk management of a diverse portfolio of products in the general medicine therapeutic area. The CSRM Physician Lead will lead a team of safety physicians, medical associates and scientists accountable for all aspects of clinical safety assessment and risk management for investigational and marketed products during the full product lifecycle. The incumbent will direct and oversee the work of physicians and scientists in ensuring the best possible understanding of the safety profile of their assigned products and in developing effective risk management plans and ensuring transparent risk communication, both throughout clinical development and following marketing authorization and commercialization.
The CSRM Physician Lead is a key senior leader in the CSRM organization and a member of the Global Clinical Safety & Pharmacovigilance Senior Leadership Team. The incumbent will partner and collaborate closely with senior leaders cross-functionally, including those in Global Clinical Development, Regulatory Affairs, Biostatistics, Legal, Global Safety and Epidemiology.
Reports directly to the Vice President, Clinical Safety and Risk Management.
Supports product development activities via oversight of staff who lead Risk Management and Safety Teams (RMST) for general medicine programs with multiple investigational/marketed products. Additionally, the incumbent will be accountable for setting the safety strategy for the rapidly emerging portfolio of general medicine assets; including those in partnership with other sponsors.
Participates in relevant Governance, Management and Oversight Committees and Teams, as described in CSRM SOPs.
May serve on Joint Steering committees or other governance for products developed under joint development agreements.
Ensures the scientific appropriateness and timely submission of all relevant agency obligations, such as: Aggregate Reports (e.g. PSUR/PBRER), Risk Management Plans, CTD submission documents (e.g. 2.7.4/ISS) and responses to Agency requests.
Accountable for the scientific strategy and deeply involved in overseeing the preparation of regulatory action in response to emerging safety concerns for product in the general medicine pipeline/portfolio; including attending agency meetings as warranted.
In partnership with the EU QPPV office, establishes and maintains good relations and effective communications with EMA and EU Member State Authorities to ensure timely communication regarding any emerging safety or compliance issues.
Partners with CSRM leadership, Vice President, Global Safety Organization and the Vice President, MRL Compliance to ensure and oversee robust Pharmacovigilance quality management programs.
Represents Merck on national and international committees on Pharmacovigilance (PV), drug safety, and risk management issues. Interacts and partners with regulatory agency representatives and industry thought leaders to provide industry input into new regulations and guidance concerning risk management and drug safety.
M.D./DO.or equivalent required
Licensed physician with documented further medical accreditation and 3 or more years of prior clinical practice experience
9-15 years of industry experience or experience in a highly related area (e.g. regulatory agency) with minimum of 5 years of experience in clinical safety / PV (or equivalent)
Prior experience as a manager of people
Broad-based knowledge of the pharmaceutical development process, global risk management requirements and demonstrated knowledge of global requirements concerning pharmacovigilance
Demonstrated ability to work effectively across functions and divisions and influence process and decisions at a senior management level
Demonstrated ability to set strategic direction for teams and effectively drive rapid disciplined decision making
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Merck & Co., Inc
Website : http://www.merck.com
Merck has a long and rich history of working to improve people's health and well-being. Through the years, our researchers have helped to find new ways to treat and prevent illness - from the discovery of vitamin B1, to the first measles vaccine, to cold remedies and antacids, to the first statins to treat high cholesterol. Our scientists also have helped develop many products to improve animal health, including vaccines and antibiotics. While we are proud of our past, we are enthusiastic about the future of this new company and we are excited to help create a healthier, brighter future for people around the world.