The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Lead-Sub-Saharan Africa and is responsible for the daily case management activities for assigned country(ies).
The Sr PV Specialist is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. He/she is also responsible for PV activities (as delegated or assigned by their Manager) which may include but are not limited to: PV intake, 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, communication of safety issues, people development, and/or special projects as assigned and is able to work on these delegated activities independently.
The Sr. PV Specialist may serve as the deputy/back-up Qualified Person for PV (QPPV) / Local PV Contact / Local Responsible PV person as required per local PV legislation. In the absence of their Manager he/she may be responsible for managing all day-to-day activities of the PV department and serves as their back-up.
Primary Activities:
1. Serves as the back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation.
2. Serves as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
3. Oversees all daily PV processes and activities within the countries covered by the country operation as required.
4. Establishes and coordinates reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
5. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
6. Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
7. Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
8. Participates in and supports audits of contractual partners/vendors as necessary.
9. Develops and maintains local PV controlled documents (i.e., SOPs, CCPDs, training materials, etc. as applicable) ensuring that they are kept current.
10. Assists in developing local procedures (in compliance with regional and standards) for the department, to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
11. Supports PV Lead in maintaining the local PV Training matrix and onboarding plans.
12. Supports training of local PV staff, company personnel, distributors, vendors, and business partners in the countries covered by the country operation and can provide training as applicable.
13. Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation. 14. May be assigned responsible for ensuring PV language is included in local agreements, liaising with business partner as required, and ensuring maintenance of BDLM with respect to local contracts.
15. Supports 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.
16. May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally.
17. May be assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
18. Participates on local company committees and councils (as appropriate) for matters impacting PV as assigned.
Background 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 and supervisory experience managing people/teams/contractors.
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.
The Senior Specialist is expected to have excellent communication and time management 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.
Some travel within the region and globally may be required.
Skills:
Primary skills include but are not limited to:
1 Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals; possesses advanced leadership skills.
2. 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.
3. 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.
4. Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally within the company that improve quality and /or add value to the business.
5. 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.
6. 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.
7. 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.
8. Regulatory and Compliance Management: Demonstrates advanced knowledge of 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.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
25%
Flexible Work Arrangements:
Flex Time
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R123035