The PV Alliance Management (PVAM) Specialist plays a key role in the PVAM Team, facilitating across functional teams, building relationships, and supporting the delivery of high-quality PV Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations operating procedures and guidelines.
- Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers.
- Support implementation for new partnerships and maintenance/change
- Support establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities.
- Interact with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO.
- Coordinate the PVA/SRP review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement.
- Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans.
- Coordinate implementation of Safety Reporting plans for programs with the potential to generate safety information.
- Coordinate PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States.
- Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs.
- Support collection of information required to update designated sections of the PSMF.
- Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global Pharmacovigilance and external PV Service Providers, and distribute final summaries to all participants, as well as senior PVAM staff. Follow up with meeting participants on the resolution of action items from meetings.
- Maintain and organize internal PVAM files (Agreements, supporting documents, meeting minutes).
- Participate in maintaining PVAM Portal and Mailbox.
- Conduct ad hoc/special projects and analyses for PVAM management.
- PVAM Specialist Essential Functions
- Adheres to company templates and GxP guidelines for documentation and communications
- Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training
- Other duties as required to support PVAM team
- Participate in the development and maintenance of PVAM activity workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced
- May serve as an individual contributor or a project manager for functional projects or workflows.
- May mentor other team members
- Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating
- Takes responsibility for personal development and continuous improvement, including keeping up to date with pharmacovigilance practices, legislation and guidelines.
- Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes
- Collaborate effectively with Quality Assurance, Legal, and Project Management.
- BS/BA degree in health related or biological science related field
- 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience
- In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area
- Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
- Experience interacting with service providers or external business partners
For more information, please contact Fandi Hatib on 01727 817 600 or email@example.com
- Agency: Achieva Group Limited
- Contact: Fandi Hatib
- Phone: +44 (0)1727 811 634
- Reference: 32193
Website: Achieva Group Limited
- Updated: 22nd December 2021
- Expires: 19th January 2022