Pharmacovigilance Specialist

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

The Pharmacovigilance Specialist (PV Specialist) reports to the Country PV Lead and is responsible for the daily case management activities for assigned country(ies).

The PV Specialist is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. They are also responsible for PV activities (as delegated or assigned by their Manager) which may include but are not limited to: PV intake, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, local training, communication of safety issues and/or special projects as assigned and is able to work on these delegated activities independently.

Primary activities:

1. Oversees all daily PV processes and activities within the countries covered by the country operation as required. 

2. 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

3. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements. 

4. 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.

5. Participates in and supports audits of contractual partners/vendors as necessary. 

6. Supports PV Lead in maintaining the local PV Training matrix and onboarding plans.

7. 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.

8. 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.

9. 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.

10. 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 (Hons degree preferred for life sciences), or medical science degree and be fluent in English (written and spoken).

They should have a minimum of 1-3  years of pharmaceutical industry experience, preferably in pharmacovigilance.

He/she must have knowledge of PV regulations for countries covered by the country operation and have knowledge of PV processes and activities.

The PV 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 well work independently and in teams. 

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1