What are the responsibilities and job description for the Associate Director - Pharmacovigilance Operations position at Actalent?
The 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 management. You will partner with key stakeholders within and outside PV to ensure the development and continuous harmonized operations of global pharmacovigilance activities while maintaining the highest standards for integrated functioning.
Responsibilities
- Provide overall leadership to support global principles and standard practices for pharmacovigilance operational activities within clinical trials and post-marketing support.
- Lead and/or review safety sections of SMPs, Investigator Brochures, DSUR, Protocols, Informed Consents, and related Safety Documents to ensure Regulatory, GCP, and Legal compliance.
- Ensure oversight of the CROs responsible for SAE reporting to Authorities and generation of periodic safety reports.
- Collaborate in Regulatory inspection preparedness and audit readiness, with a focus on U.S. and EU/EMA Regulations.
- Assist in Safety Database set-up and performance, including database validation checks.
- Participate in safety or clinical audits of CROs/vendors.
- Collaborate in related Biometrics processes, such as DMP reviews, IDMC Charter reviews, DMC meetings attendance, eCRF and CCG reviews, SAE Reconciliation.
- Provide expert 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.
- Attend meetings with CROs/vendors and DMC meetings.
Essential Skills
- Minimum of 8 years of related job experience.
- Knowledge of FDA, EMA, and other Regulatory adverse event reporting regulations.
- Ability to interpret and apply applicable regulations to resolve safety issues.
- Excellent oral and written communication skills.
- Strong collaboration and leadership skills.
- Expert scientific knowledge.
- Organization and time management skills.
- Strategic thinking and influencing skills.
- Vendor oversight and stakeholder management.
- Complex problem-solving ability and sound judgment.
- Medical and technical writing experience.
Additional Skills & Qualifications
- 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.
- Ability to work in a complex and evolving environment.
- Ability to travel to support company meetings (up to 10%).
Pay and Benefits
The pay range for this position is $90.00 - $100.00/hr.
Workplace Type
This is a fully remote position.
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 & Inclusion
At 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 people
The 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.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $90 - $100
