Responsible for the direct management of activities related to Pharmacovigilance system, compliance assurance with global Regulatory Health Authorities, and serving as Deputy QPPV. Role involves support for both commercially marketed and development products, the assessment of emerging safety signals, assessment and recommendations for labeling, and oversight of our clients’ distributors/vendors to ensure compliance.
Sr. Pharmacovigilance Manager (QPPV)
- Provide oversight of services provided by the pharmacovigilance vendor, ensuring compliance with local and global regulatory requirements.
- Support for Regulatory Authority audits/inspections related to pharmacovigilance.
- Review of CIOMS and Medwatch reports for accuracy and content prior to submission.
- Support global PV reporting obligations to Regulatory authorities.
- Support and enhance existing operating procedures and controls.
- Build strong working relationships with internal stakeholders, PV vendor(s), and distributors.
- Support the development and oversight of Safety Data Exchange Agreements.
- Manage/oversight of risk mitigation measures; recommend measurements/modifications.
- Support company adverse event training for our client’s staff.
- Review and recommend safety-related revisions to product labeling/investigational materials.
- Support PSMF oversight/management and revision.
- Support medical information responses.
- Respond/assist with inquiries from Regulatory authorities, vendor/partners, and distribution partners.
- Ensure compliance with regulatory reporting obligations related to our client's products and development candidates.
- Review/revise/communicate metrics relative to PV system performance/compliance.
- Oversight of literature review in support of safety management systems and regulatory reporting.
- Support safety review and assessments of clinical data on development candidates. Assist in preparation of regulatory submissions in support of development programs.
- Assist in the conduct of business diligence activities.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Minimum of 5 years direct pharmacovigilance experience, preferably with pharmaceuticals and/or biologics.
- Minimum bachelor’s degree in science-related discipline; advanced degree preferred.
- Demonstrated experience in pharmaceutical/ biologics process validation/tech transfer activities
- Proficiency in use of Argus drug safety database or equivalent with strong expertise in Microsoft office
- Experience in Drug Safety Applications and Regulatory compliance applications a plus knowledge of 21 CFR Part 11 guidelines, EMA GvP modules, Computer system validation guidelines
- Demonstrated experience in the review and application of risk management processes
- Understanding of pharmaceutical development.
- An ability to contribute to a team environment.
- Excellent organizational and relationship management skills
- Excellent oral and written communication skills; technical writing capability.
- Strong knowledge of PV quality systems and regulatory requirements across US/Canada and other health authorities.
- Strong technical and problem-solving skills/experience.
PREFERRED SKILLS AND EXPERIENCE:
- Experience with ROW PV requirements (multi-country).
- Experience in development safety assessments
- Regulatory Authority inspectional experience.
- Medical information handling experience
Position may include US/Canada or other global partner locations.