Description
\t\t\t\t\tThe PV Operations, Associate Director is accountable for the development and execution of global pharmacovigilance processes and deliverables. This position will also play a critical role in supporting on-going clinical trials and vendor oversight.• You will partner with key stakeholders within and outside PV to ensure development and continuous harmonized operations of global pharmacovigilance activities and maintain highest standards for integrated functioning.• As part of the pharmacovigilance operations team, you will report to the VP and Head, Clinical Development and will be responsible for overall leadership to support global principles and standard practices for pharmacovigilance operational activities within clinical trials and post marketing support.• Leading and/or editing/reviewing of safety sections of SMPs, Investigator Brochures, DSUR, Protocols, Informed Consents, related Safety Documents etc. to help ensure Regulatory, GCP, and Legal compliance. • Ensure oversight of the CROs responsible for DSPV-SAE reporting to Authorities and generation of periodic safety reports.• Collaborate in Regulatory inspection preparedness/audit readiness (with a focus on U.S. and EU/EMA Regulations).• Assist in Safety Database set-up and performance (may include database validation checks).• Participate in DSPV or Clinical audits of CROs/vendors.• Collaborate in related Biometrics processes (e.g., perform DMP reviews, IDMC Charter reviews, attend DMC meetings, perform eCRF and CCG reviews, SAE Reconciliation etc.).• Provide DSPV advice and guidance to other functional groups as needed• Interface with other functional groups to ensure harmonization of processes and data collection/content as needed (e.g., Clinical Operations, Clinical Development, Regulatory Operations, Regulatory Affairs, Biometrics/Data Management, Quality Management, etc.).• Attend meetings (e.g., DSPV meetings with CROs/vendors, DMC meetings)• Location: Continental USA or Canada; other locations may be considered.
\t\t\t\t\tSkills
\t\t\t\t\tpharmacovigilance, Inspection readiness, Compliance, Vendor management, drug safety, PV Operations, cross functional teams, DSPV, FDA, EMA, GCP, Safety, rare disease
\t\t\t\t\tTop Skills Details
\t\t\t\t\tpharmacovigilance,Inspection readiness,Compliance,Vendor management,drug safety,PV Operations,cross functional teams
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t• At a minimum, completion of an undergraduate degree in a scientific discipline (BS/BSc/Nursing), completion of a graduate degree is an asset (PharmD, MS, NP, MD). Experience in supporting clinical trials and post marketing preferred.• A minimum of 8+ year of related job experience is required for this position. • Knowledge of FDA, EMA, and other Regulatory adverse event reporting regulations and demonstrates the ability to interpret and apply applicable regulations to resolve safety issues.• Excellent oral and written communication skills and interpersonal skills; strong collaboration and leadership skills; expert scientific knowledge; organization and time management skills; strategic thinking and influencing skills.• Vendor oversight, stakeholder management and demonstrated complex problem-solving ability and sound judgement ability.• Medical and technical writing experience.• Ability to work in a complex and evolving environment. • Ability to travel to support company meetings (up to 10%)
\t\t\t\t\tExperience Level
\t\t\t\t\tExpert Level
Pay and Benefits
The pay range for this position is $90.00 - $100.00
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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