Senior Pharmacovigilance Specialist

Senior Pharmacovigilance Specialist

Department: Pharmacovigilance

**Job Type**: Full‐time
Reports To: Director of Pharmacovigilance Services
Work Remotely: Yes

About Med Communications

Med Communications is dedicated to delivering high-quality medical affairs, pharmacovigilance, and commercial solutions to pharmaceutical, biotechnology, and medical device companies while building positive, outgoing client relationships and providing employees with a meaningful professional experience. With over 20 years of medical affairs experience in the pharmaceutical, biotechnology, and medical device industries, Med Communications has emerged as a leading medical affairs service provider.

What You Will Do

The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products.
The Senior Pharmacovigilance Specialist has extensive knowledge of formal requirements and guidelines; document, format, and content expertise; writing, communication, and project management skills, in order to ensure that the presentation of patient safety, the products’ benefit/risk profile and the company’s risk management assessments to regulatory authorities are clear and consistent across the whole suite of PV documents, and that these documents are produced in a timely and efficient manner.

Main Requirements

To perform this job successfully, an individual must be able to perform each of the following essential duties satisfactorily:

- Demonstrates ongoing scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape, as per assigned projects.

.Integrates scientific expertise with knowledge of safety database functions to ensure comprehensive case entry and identification of follow-up requirements for cases from multiple sources and for multiple case types, such as spontaneous, clinical trial, post-authorization safety studies, etc.
- Demonstrates proficiency in the use of the safety database and associated safety system(s).
- Accurate data entry in the safety database.
- Demonstrates proficiency with MedDRA and WHODrug coding.
- Completes medical literature search activities for pharmacovigilance purposes.
- Completes social media search activities for Client products for pharmacovigilance purposes.
- Knowledge of regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the appropriate entities.
- Knowledge of regulatory and compliance guidelines to ensure periodic report submission to the appropriate entities.
- Knowledge of regulatory and compliance guideline to ensure risk management activities are completed and reported within regulatory determined timelines to the appropriate entities.
- Integrates scientific expertise with knowledge of safety database functions to ensure comprehensive risk management, signal detection and surveillance activities are conducted for the products of responsibility.
- Other pharmacovigilance activities as requested.

Education: Degree in Life Sciences (pharmacy, nursing, medicine, veterinary) or Bioscience (biochemistry, biotechnology, biology) or similar. Advanced degree in pharmacy (PharmD preferred) or relevant, equivalent clinical experience.

Experience: Minimum of three years related experience in Biotech, Pharma or Clinical Research organization.. Demonstrated expertise in pharmacovigilance activities with drugs, devices, biologics and combination products preferred.
- Advanced level of spoken and written English and good communication skills;
Computer Skills: Prefer proficiency with Embase, Ovid Medline, PubMed, Microsoft Office products, safety databases such as Oracle Argus Safety, ARISg and SafetyEasy, and content management systems.

Prefer pharmaceutical industry experience including an understanding of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.
- Above average attention to detail, teamwork and initiative:
What We Offer
- Work from home opportunity with all the required equipment;
- Opportunity for career development;
- Training on-the-job with integration on real client projects;
- Salary package and benefits according to demonstrated experience and responsibilities inherent to the function.

Ability to commute/relocate:

- Lisboa, Distrito de Lisboa: Reliably commute or willing to relocate with an employer-provided relocation package (required)