An excellent opportunity has arisen for a PV Alliance Management Specialist to join my client on a 2-year contract basis. Within this role you will be working across functional teams, building relationships, and supporting the delivery of high-quality PV Agreements. You will need to be well versed on PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and act as key contact person for internal and external customers, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff.
Working with the PVAM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs and participate in vendor governance.
- 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.
- 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
Required Knowledge, Skills, And Abilities
- 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
- Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships
- Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence
- Ability to work effectively within a matrix organization to achieve desired outcomes
- Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives
Please contact Lewis Coulson on firstname.lastname@example.org or +441727817622 for further details.
- Agency: Achieva Group Limited
- Reference: LC-24
Website: Achieva Group Limited
- Posted: 9th January 2023
- Expires: 6th February 2023