Talent.com
Vice President and Head of Clinical Safety and Pharmacovigilance
Vice President and Head of Clinical Safety and PharmacovigilanceFairway Consulting Group • East Coast
Vice President and Head of Clinical Safety and Pharmacovigilance

Vice President and Head of Clinical Safety and Pharmacovigilance

Fairway Consulting Group • East Coast
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]
Our client is a clinical-stage biopharmaceutical company developing novel cell therapies for cancer. They have asked us to assist them in their search for a Vice President and Head of Clinical Safety and Pharmacovigilance.

Reporting to the Chief Medical Officer, this role leads the strategic and operational management, planning, and execution of clinical safety, pharmacovigilance, and risk management for early and late-stage clinical development programs in compliance with the appropriate regulatory guidelines.

Major tasks and responsibilities include:
  • Organizes and oversees product safety surveillance and evolving safety profiles for products in clinical development as well as marketed products.
  • Contribute to the Company’s overall clinical development strategy as a member of the Chief Medical Officer’s leadership team.
  • Collaborates with all areas of Clinical, Quantitative & Decision Sciences, Regulatory, CMC, Commercial, Clinical Research internally, as well as site investigators, contract research organizations (CROs) and drug development collaborators/partners to ensure that clinical safety and pharmacovigilance are implemented effectively and strategically across all planned and ongoing clinical trials.
  • Reviews and approves drug safety information from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA.
  • Identifies and analyzes safety signals emerging from individual or aggregate safety event analyses: performing analyses of specific events across studies, as indicated.
  • Develops and implements SOPs and other controlled documents to support investigational and ultimately, marketed product safety surveillance.
  • Oversees investigational and/or approved drug safety updates, SUSAR and investigational new drug, safety reports, investigator communications, Development Safety Update Reports (DSURs) and other reports as necessary.
  • Participates on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents providing safety content.
  • Liaises with Medical, Clinical Operations, Quantitative & Decision Sciences, Regulatory Affairs, Quality and Compliance to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders including publications and corporate documents.
  • Leads the PV team; includes setting strategy and objectives, delegating and motivating, communicating regularly, career development planning, mentoring and guidance.
  • Oversees development of Clinical Safety and Pharmacovigilance training programs for both internal and external use related to implementing, executing, and maintaining safety processes and systems.
  • Monitors CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials.
  • Leads team through pre-launch/launch efforts for company’s first commercialized product.

We seek candidates with the following qualifications:
  • Must have a medical degree with relevant clinical experience, preferably in oncology, hematology, and/or immunology.
  • Requires a minimum of 12 years combined in international pharmacovigilance/drug safety pharmaceutical industry and clinical medical practice experience.
  • Previous leadership, management, and cross functional matrix experience required.
  • Expert knowledge of international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety.
  • Requires the ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors.
  • Must be a strong functional and matrix leader with demonstrated leadership skills and the ability to influence across external functions and within internal teams.
  • Requires a high degree of flexibility and learning agility, and the ability to work in changing, fast-paced and sometimes ambiguous environments.
  • Must be an excellent collaborator and team player with demonstrated high degree of emotional intelligence in working with others.
  • Excellent, concise verbal and written communication skills are required.
  • Effective presentation skills are required since this role will interact with governance bodies, the Executive Team and at times, the Board of Directors as well as external parties.
  • Requires the ability and willingness to “roll up sleeves” to get work accomplished, in addition to being a big picture, strategic thinker.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 40 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.
[job_alerts.create_a_job]

Vice President and Head of Clinical Safety and Pharmacovigilance • East Coast

[internal_linking.similar_jobs]

Assistant Vice President of Psychiatry

Maimonides Medical CenterBrooklyn, NY, United States
[job_card.full_time]

We're Maimonides Health, Brooklyn's largest healthcare system, serving over 250,000 patients each year through the system's 3 hospitals, 1800 physicians and healthcare professionals, more than 80 c...[internal_linking.show_more]

 • [job_card.promoted]

Vice President, Real World Evidence (RWE)

Recursion PharmaceuticalsNew York, NY, United States
[job_card.full_time]

Vice President, Real World Evidence (RWE).New York, New York; Salt Lake City, Utah.Recursion is currently seeking a seasoned leader to join our team as Vice President, Real World Evidence.This role...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Vice President, AML Compliance Officer

Wedbush SecuritiesNew York, NY, United States
[job_card.full_time]

Wedbush Securities is one of the largest securities firms and investment banks in the nation.We provide innovative financial solutions through our Wealth Management, Investment Banking & Capital Ma...[internal_linking.show_more]

 • [job_card.promoted]

Vice President, Client Experience

DNA Communications IncNew York, NY, United States
[job_card.full_time]

Vice President, Client Experience.A hungry, strategic, creative, collaborative account leader who wants to make a difference on the accounts you work on and the agency you join.A fast-growing, smal...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

VP of Compliance

Essen Medical AssociatesBronx, NY, United States
[job_card.full_time]

At Essen Health Care, we care for that!.As the largest privately held multispecialty medical group in the Bronx, we provide high-quality, compassionate, and accessible medical care to some of the m...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Vice President, Regulatory Transformation - Capital Markets

Bank of MontrealNew York, NY, United States
[job_card.part_time]

BMO Capital Markets is a leading, full-service financial services provider.We offer corporate and investment banking, treasury management, as well as research and advisory services to clients aroun...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Regional Vice President, Health Services Southeast Region

HumanaNew York, NY, United States
[job_card.full_time]

Job Description Summary The Regional VP, Health Services relies on a medical background to create and oversee clinical strategy for the region.The Regional VP, Health Services requires an in-depth ...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Senior VP, Health & Well-Being - Growth & Strategy

MMC IncNew York, NY, United States
[job_card.full_time]

A leading communications agency in New York seeks a Senior Vice President to lead strategic direction for key healthcare accounts.This role involves high-level client counsel, team leadership, and ...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Investment Banking Vice President | Healthcare Services

Houlihan LokeyNew York, NY, United States
[job_card.full_time]

Vice President, Healthcare Group.NYSE:HLI) is a leading global investment bank recognized for delivering independent strategic and financial advice to corporations, financial sponsors, and governme...[internal_linking.show_more]

 • [job_card.promoted]

Healthcare M&A VP: Lead Deals & Client Strategy

JPMorgan Chase & Co.New York, NY, United States
[job_card.full_time]

A leading global financial services firm in New York is seeking an experienced Vice President in M&A.This role requires managing client relationships, overseeing transactions, and leading negotiati...[internal_linking.show_more]

 • [job_card.promoted]

Vice President, Earned Media / PR (Health & Pharma)

Allison WorldwideNew York, NY, United States
[job_card.full_time]

Vice President Of Earned Media / Pr.We are seeking a vice president of earned media / pr to lead integrated communications strategy across healthcare, pharmaceutical, and bioscience clients.This ro...[internal_linking.show_more]

 • [job_card.promoted]

Executive Director of Psych

CarePoint Health SystemBayonne, NJ, United States
[job_card.full_time]

Executive Director Of Behavioral Health & Detox Services.The Executive Director of Behavioral Health & Detox Services is a key system-level leadership role responsible for the strategic direction, ...[internal_linking.show_more]

 • [job_card.promoted] • [job_card.new]

Vice President, Auditor, Enterprise and Operational Risk

BNY ArcherNew York, NY, United States
[job_card.full_time]

Vice President, Auditor, Enterprise and Operational Risk.At BNY, our culture allows us to run our company better and enables employees' growth and success.As a leading global financial services com...[internal_linking.show_more]

 • [job_card.promoted]

Vice President of Institutional Advancement

InsideHigherEdNew York City, New York, United States
[job_card.full_time]

Vice President of Institutional Advancement | Touro University.Established in 1970 to focus on higher education for the Jewish community and humanity, Touro is now the largest higher education syst...[internal_linking.show_more]

 • [job_card.promoted]

VP of Technology: Growth, Security & Scale

Sollis Health FL, Inc.New York, NY, United States
[job_card.full_time]

A healthcare technology firm based in New York seeks a Vice President/Head of Technology to lead its technological transformation.The role involves developing technology strategies, ensuring operat...[internal_linking.show_more]

 • [job_card.promoted]

Vice President, Lead Auditor – Regulatory Compliance(investment banking)

Employvision Inc.New York, NY, United States
[job_card.full_time]

The Vice President, Lead Auditor will lead internal audits focused on U.This role requires strong knowledge of financial regulations, including Regs D, O, W (“alphabet regs”), and broker-dealer com...[internal_linking.show_more]

 • [job_card.promoted]

Vice President, Health Media

Daniel J Edelman HoldingsNew York, NY, United States
[job_card.full_time]

Vice President Of Health Media.Edelman is seeking a strategic, forward-thinking Vice President of Health Media to help lead the next generation of healthcare and pharmaceutical storytelling.This ro...[internal_linking.show_more]

 • [job_card.promoted]

SVP, Chief Medical Officer

Health Alliance of Hudson ValleySuffern, NY, United States
[job_card.full_time]

Summary: The System Chief Medical Officer will be a leader in the creation of the "ideal patient experience," by developing, implementing and monitoring systems and processes that ensure the highes...[internal_linking.show_more]