Head Pharmacovigilance & Medical Affairs
Company: Disability Solutions
Location: Princeton
Posted on: September 14, 2023
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Job Description:
At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's,
you will contribute to making the breakthroughs of tomorrow a
reality today! From making medicines more affordable to discovering
innovative treatment options to satisfy unmet medical needs, we are
dedicated to helping people lead longer and healthier lives. We are
seeking dynamic and energetic individuals ready to inspire, ready
to make a difference for their community and every
community.Diversity, Equity & InclusionAt Dr. Reddy's, we are
deeply committed to building a diverse, equitable and inclusive
workplace where everyone belongs and is valued for their
contributions to the team. We are most interested in finding the
best candidate for the role and are open to exploring candidates
with a less traditional background. Purpose: We are seeking an
exceptional leader to Head Pharmacovigilance and Medical Affairs
including medical information function for Dr Reddy's North America
Generics and affiliates as well as Dr. Reddy's Canada. Incumbent
will drive Medical Affairs strategies and be responsible for
accurate patient safety data. Provide oversight on medical
information services and support in providing strategic inputs to
cross functional teams as well as initiate, improve and monitor the
execution of existing systems. Responsibilities:--- Manage, create
(vendor) and review ICSR (US/Foreign), PSR reports from clinical
and medical standpoint, identify and respond to signal analysis,
and submit to regulatory agency (FDA/Health Canada) within
timelines to achieve 100% compliance with US pharmacovigilance
regulatory norm --- Anchor drug safety regulatory inspection in US
(FDA regulatory agencies),participate in audits and provide support
in external audits. Responsible for driving successful PV audits to
achieve no critical findings and provide post inspection report
with corrective action plan--- Identify pharmacovigilance processes
and procedures to be documented and set up. Establish the
pharmacovigilance Quality Management System and achieve compliance
with US regulatory requirements --- Review current reporting period
against historical data to conduct detail evaluation of risks /
identify potential risk areas. Review existing products for safety
risks and generate report on product risk-benefit ratio and develop
proposal for regulatory agencies and manage the REMS program,
budget and ensure regulatory sign off and take corrective actions
when necessary --- Support in the development and execution of
North America Medical Affairs plans and Dr. Reddy's Canada Medical
Affairs plans in consideration of best clinical practices and
overall corporate objectives aligned with commercial Brand strategy
--- Provide oversight of the medical information services for North
America and ensure seamless communication with Pharmacovigilance
service providers --- Engage effectively cross-functionally,
maximizing functional reporting relationships, and ensure
successful implementation of company strategies. Support scientific
congress attendance via pre-meeting planning and post-meeting CI
reporting --- Support global Pharmacovigilance digitalization
efforts to increase efficiency, quality & productivity while
ensuring that the deliverables are 21CFR Part 11, GAMP 5 and GxP
compliant Qualifications/Skills:--- Advanced scientific degree -
MD, PhD, PharmD or other degree with 10+ years in PV & Medical
Affairs in the pharmaceutical industry--- Understanding of North
American pre-and post-marketing regulatory requirements for medical
Affairs and Medical Information activities--- Knowledge of FDA and
Health Canada: Drug Discovery and Development Processes; Clinical
Development Tools and Processes; Medical Affairs Guidelines;
Regulatory Guidelines; Pharmacovigilance Guidelines; Domains across
the pharma value chain--- A collaborative team player with ability
to work successfully across teams and functions--- Proactiveness
with attention to detail--- Excellent communication skills (verbal
& written); MS Office suite--- Demonstrated ability to manage
various projects, solve problems, deliver on commitments, and work
with multidisciplinary teams Must be a U.S. citizen or lawful
permanent resident of U.S. or otherwise authorized to work in the
U.S. without requiring sponsorship now or in the future.COVID-19
VaccinationGetting vaccinated remains the most effective way to
halt the spread of the COVID-19 pandemic, and Dr. Reddy's
encourages all employees to be vaccinated. At this time,
vaccinations are not mandated for Princeton-based employees but may
become required in the future. Equal Opportunity Employer: An Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability.
Keywords: Disability Solutions, Trenton , Head Pharmacovigilance & Medical Affairs, Accounting, Auditing , Princeton, New Jersey
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