6 Jan '21
Country Pharmacovigilance Lead

Medical, Gauteng Gauteng

market - related

A Global Pharmaceutical Company has a vacancy for a Pharmacovigilance Lead.

Job Purpose:

  • The Country Pharmacovigilance Lead reports to the PV Regional Head / Regional PV Lead and may manage a team of PV personnel.
  • He/she is accountable for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. He/she is also responsible for other activities which may include but are not limited to: management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, management of local safety issues, communication of safety issues, people development, or special projects as assigned, and is able to work on these delegated activities independently.
  • The Country PV Lead is also responsible for ensuring compliance with local laws and regulations, company policies and procedures. He/she is the primary point of contact for the local Health Authority and serves as the local Qualified Person for PV (QPPV) / Local PV Contact / Local Responsible PV Person for their country (& supported countries where applicable) and ensures a back-up as required per local PV legislation. The Country PV Lead ensures collaboration with the local Managing Director, Global Medical Affairs (GMA), Legal, and Manufacturing colleagues and other business unit colleagues to obtain alignment on issues arising from and/or impacting PV. He/she may be a part of the local leadership team and is a member/lead of the relevant local governance council.


Key Responsibilities:

  • Responsible for strategic leadership of the PV short and long-term country objectives including department structure/function/processes, PV Intelligence and local Health Authority policy development / implementation.
  • Responsible for management of local resources, as applicable, including recruitment, training, development and performance management.
  • Serves as the as the local Qualified Person for PV (QPPV) / Local Responsible PV person (LRP) as required per local PV legislation.
  • Oversees all daily PV processes and activities within the countries covered by the country operation.
  • Establishes and coordinates reconciliation processes of AE reports received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
  • Coordinates the filing, storage and archiving of safety-related documentation in accordance with company’s policies and local requirements.
  • Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation
  • Prepares for audits/inspections for countries covered by the country operation and actively participates in the audit and/or inspection. Provides recommendations of corrective and preventive actions (CAPA), tracks CAPA commitments to address findings/observations and monitors until closure.
  • Participates in and supports audits of contractual partners/vendors as necessary.
  • Defines and develops local standards and procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
  • Develops and maintains local PV controlled documents (i.e. SOPs, training materials, CCPD (where applicable)) ensuring that they are kept current
  • Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
  • Ensures training of PV staff, as applicable, (including maintenance of the local training matrix and onboarding plans).
  • Supports training of local company staff, distributors, vendors, and business partners in the countries covered by the country operation and can provide training as applicable.
  • Ensures PV language is included in local agreements, liaising with business partner as required, and ensuring maintenance of BDLM with respect to local and regional contracts.
  • Responsible for reviewing and approving local initiatives (e.g. digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
  • Responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations.
  • Conducts qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements when required
  • Provides expertise in the planning, execution, and maintenance of major projects.
  • Represents PV in cross-functional organizational and alliance partner forums as needed.
  • Serves as local Subject Matter Expert on relevant PV regulations, processes and procedures.
  • Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions (i.e., new clinical trials, product launches, etc.)
  • Participates on local company committees and councils (as appropriate) for matters impacting PV.

Requirements:

  • The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language.
  • He/she should have a minimum of 5 years of industry experience in in pharmacovigilance.
  • Supervisory experience managing people/teams/contractors may be required depending on the PV structure in place in the country.
  • He/she must have in-depth knowledge of PV regulations for countries covered by the country operation and be an expert in PV processes and activities.
  • A knowledge of quality management system standards is required as well as experience interfacing with internal auditors.
  • Experience interfacing with health authority inspectors is an advantage.
  • The Country PV Lead is expected to have excellent communication, time management, decision-making, problem-solving and leadership skills, the ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.

Skills:

  • Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals; possesses advanced leadership skills.
  • Communication Skills: Demonstrates advanced communications skills to convey and receive information in English and local language. Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills and ability to adapt presentations to various audiences.
  • Problem Solving: Demonstrates advance skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
  • Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
  • Project Management: Demonstrates advance skills in the ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
  • Decision Making: Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
  • Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.
  • Regulatory and Compliance Management: Demonstrates advanced knowledge of PV regulations and regulatory trends to ensure the functional areas within the company are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

 

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

 

Ad Visible Until: 31 January 2021
Ref: DBN002835/SS

Vacancy Type: Permanent