Local Contact Person for Pharmacovigilance and

Company Description
PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report.

This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.

Job Description**
KEY ACCOUNTABILITIES**:
The LCPPV/LCPRA is responsible for supporting with local PV/RA services. They provide franchise liaison between Ergomed Plc/ PrimeVigilance and client on a multiple projects’ program. They also provide strategic/advisory guidance to other members of the RA & PV Network team
**LCPPV responsibilities**:

- Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
- Prompt and effective communication with local regulatory authorities
- Provision of local regulatory intelligence screening
- Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
- Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
- Support audits and Inspections
**LCPRA responsibilities**:

- Contact point for NCA
- Assistance with local RA portals (if applicable for the country)
- Participation on local administrative documents for submission
- Review and linguistic input on local Product Information and Mock-ups
- Collecting RA Regulatory Intelligence
- Ad hoc local regulatory advice
- Attending teleconferences
- Reporting RA activities to the Client electronically
**Local Literature Screening (if applicable)**
- Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information regarding Client’s medicinal products and those of the same class
- Provide English summary/translation of the detected literature articles (for all suspected ADRs and potentially relevant safety information)
- Provide Local Literature Screening tracker monthly to the Project Manager
**LCPQA responsibilities (if applicable)**

To handle local tasks such as:

- Quality complaints (received from HA, distributor, customer)
- Deviations (received from HA, distributor, customer)
- Quality alerts (received from HA)
- Suspected falsified products
- Other quality-related requirements received from the local market (HA, media, distributors, wholesalers, pharmacists, health-care professionals, customers).

Qualifications**
Qualifications and Experience**
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
- Minimum 3 years within pharmaceutical or CRO industry or Regulatory body
- Minimum 2 years within LCPPV/LCPRA roles
- PV training and/or working experience and other educational or professional background as required locally
- Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency
- Knowledge of ICH GCP preferable
- Proficiency in English, both written and verbal and in local language(s
- **Special skills**
- Strong planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills
- Exceptional written and verbal communication skills to clearly and concisely present information
- Outstanding interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Remarkable attention to detail
- Ability to exercise sound judgment and make decisions independently

Additional Information
All your information will be kept confidential according to EEO guidelines.
**Our Offer**:

- Work within a successful, highly qualified and dynamic team
- Professional training and career development in a fast-growing healthcare company