I'm currently working as a pharmacovigilance specialist for a clinical research service provider. What is the usual pay in this position and how far can I get without getting a PharmD? From what I found, the prospect seems lucrative but I wonder if that only applies to people with a PharmD or MD. Any input is appreciated!
Why YSK: I am a professional pharmacovigilance case processor and reports like this could really prove to be useful in times like these and could actually help the pharmaceutical companies to make their medications more effective.citation
Je voudrais partager avec vous mon expérience du parcours vaccinal, du point de vue d'un jeune futur papa pro-vaccin et plein de bonne volonté.
Avec ma compagne, on revient de l'étranger, dans un pays où nous n'étions pas prioritaires pour nous faire vacciner. Le jour même où nous avons mis un pied en France, nous avons pris rendez-vous pour nous faire vacciner. Ma compagne était alors enceinte de 3 semaines.
On a fait la queue dans le grand centre vaccinal de Toulon, très fiers d'être de retour en France et de le voir si plein, si bien organisé, d'avoir enfin accès au sésame.
Et là patatras : moi je me fais piquer sans encombres, mais la médecin suspend son geste pour ma compagne quand elle lui annonce être enceinte au premier trimestre.
Nous avions raté l'info, mais la vaccination était déconseillée pour les femmes enceinte avant la 16è semaine.
Flash forward au 12 juillet, 3 jours plus tard. Macron annonce le pass sanitaire, ma femme ne pourra pas entrer dans un centre commercial, prendre un café, aller au restaurant sans un écouvillon dans le nez. A priori, les tests pourraient être remboursés pour elle, mais il n'est pas encore question d'un régime dérogatoire.
Pour le coup, on appelle le centre de pharmacoviligance pour avoir un second avis étant donnés les enjeux (reprise du variant Delta, les femmes enceintes sont plus à risque pour formes graves, etc...). Très gentille, la doctoresse nous confirme au téléphone que d'un point de vue de pharmacovigilance, il faut effectivement attendre. Il y a un manque de recul total sur les risques sur le développement du foetus et sur les risques de fausse couche, sans parler de potentielles complications pour la femme enciente.
Et hier, sur FranceInfo pendant qu'on était sur l'autoroute : les femmes enceintes exclues de toute dérogation au pass sanitaire, incitées à se faire vacciner (par qui ? par quoi ? sous quel prétexte ?). Confirmé ici en toute lettres : Une liste très restreinte de trois cas de contre-indication vaccinale a été établie [...] Le cas des femmes enceintes n'en fait pas partie.
Nous on se dit : cette fois c'est du sérieux. S'ils incitent à la vaccination, c'est que le doute est levé pour les femmes enceintes.
Je rappelle pl
... keep reading on reddit ➡Spoiler alert: the answer is "NO!"
Editorial: If Vaccine Adverse Events Tracking Systems Do Not Support Causal Inference, then “Pharmacovigilance” Does Not Exist
I work for a med info department in a CRO and have been interviewing with many companies, getting either to the 2nd to last or final interview rounds, but I keep getting rejected. For most interviews, I asked a question about adverse event reporting policies/expectations, but I wonder if asking this is a bad idea in hindsight.
For the record, these types of roles are ones where PV issues are more likely to be encountered, e.g. patient access liaison (field role with patient contact), med info manager (through quality checking cases submitted by call center agents per job description), etc. I asked a ton of other more pertinent questions, but like to tack on the PV handling question just for the sake of my curiosity.
For folks in pharma... do you feel like this is a question that should be completely avoided during job interviews, even if tangentially relevant for the role?
Alphanumeric is hiring a Pharmacovigilance Associate to work in Research Triangle Park, NC with one of the largest pharmaceutical companies in the world.
The PV Associate is responsible for supporting PADER/PAERs submissions and other activities to support the US Safety Governance LOC which includes and are not limited to SDEAs, Safety Mailbox , and management of AE reports.
Responsibilities Include::
- Serve as support for internal/external audits and inspections
- Perform management monitoring activities
- Manage group email and triage emails based on information provided by client
- Manage incoming information, which may include time-sensitive notifications
- Triage mailbox/postal mail which includes handling of returned products
- Support in archiving information to relevant storage areas and managing file and storage solutions (e.g. share area and team sites)
- Assist with documentation of various processes related to PV activities
- Assist with other tasks as needed to support US Safety Governance activities
Skills/Education/Experience:
- Experience in compliance monitoring
- Experience with safety database (i.e. Argus) and document management system (i.e. Veeva Vault) preferred
- Experience with IND and PADER required
- Solid understanding of Pharmacovigilance and regulatory reporting requirements in a pharmaceutical company setting
- Ability to work onsite in RTP, NC preferred
- Self-directed/motivated, strong oral and written communication skills, sound organizational skills, attention to detail
- Self-motivated and capable of working independently
- 1-2 years clinical safety, drug safety/PV or related experience
- Knowledge of GCP, clinical safety documentation and reporting adverse events
- Understanding of medical and drug terminology
- Knowledge of pharmaceutical products preferred
This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII
If interested please DM or email me directly (madkins@alphanumeric.com)
Lareb is the first pharmacovigilance agency in the world to point out PSSD in 2012 by submitting 19 reports received.
Now there's this among the abstracts in the
20th ISoP Annual Meeting “Integrated pharmacovigilance for safer patients” 8–10 November 2021 Muscat, Oman (Hybrid meeting)
P060 Persistent Sexual Dysfunction in SSRI Users: Scoping Review and Presentation of 93 Cases from The Netherlands
K. Chinchilla 1, F. van Hunsel 1, C. Ekhart 1
1 Netherlands Pharmacovigilance Centre Lareb, Signal Detection, ‘s-Hertogenbosch, The Netherlands
Background/Introduction: SSRIs are potent disruptors of sexual function. These effects can persist after the discontinuation of the SSRI, leading to Post SSRI Persistent Sexual Dysfunction (PSSD). This refers to a hypodynamic sexual state that can persist for decades carrying a high impact on the patient’s life (1, 2).
Objective/Aim: To map the characteristic factors related to PSSD through a literature review, and present the cases of PSSD received by the Netherlands pharmacovigilance centre Lareb.
Methods: A systematic literature review was performed following the PRISMA-ScR guidelines (3) to identify different aspects that describe PSSD. The search was conducted in PubMed and The Cochrane library using the keywords: SSRI prolonged sexual dysfunction, SSRI permanent sexual dysfunction, PSSD and Post SSRI sexual dysfunction. Articles published between 2000 and 2020 were included.
In addition, all reports submitted to Lareb between 1991 and 2021 with an SSRI as suspected drug and the persistence of the following ADRs: sexual dysfunction, erectile dysfunction, loss of libido, libido decreased, anorgasmia, ejaculation disorder or ejaculation failure were manually reviewed and analyzed.
Results: PSSD symptoms (Table 1) can emerge during treatment and endure or can appear after the withdrawal of the SSRI. There are no particular patient susceptibility characteristics and it can happen with all SSRIs. It is difficult to diagnose PSSD because sexual dysfunction can be seen as a sign of depression relapse and patients who express these sexual complaints frequently face lack of credibility and underestimation. The available treatment to alleviate the symptoms have little to no benefits and more research is needed to understand the mechanisms causing PSSD (1, 4, 5).
A total of 93 reports of PSSD were identified with the following ADRs: loss or decrease of libido (n = 56), erectile
... keep reading on reddit ➡Hi All!
I'm a recent graduate and I got my bachelors degree in biology. I have two job offers on the table both for around the same salary. One is a pharmacovigilance specialist position for a vaccine, it's remote, and it's a contract position for only about seven months (it's paid hourly but if I convert it to annually it'd be a little over 50k). The other is a life science recruiting position and it's a little over 50k plus commission. This recruiting job is permanent + remote (at least for the time being). Basically my question is, what can I do with this pharmacovigilance specialist experience if I decide to move forward with it? Has anyone who has started out in a similar situation to mine recommend it? What does job growth look like. I like recruiting because I'm a people person and I work at a desk, plus I don't have to deal with a job search for a while. I don't ever want to work in a lab which was what my degree was seeming to lead me towards. However, I like the pharmacovigilance role because after seven months or even during I can move anywhere I want, I'm not tied to my city. Any advice would be great! Thank you!
Quilichini JB, et al. Comparative effects of 15 antidepressants on the risk of withdrawal syndrome: A real-world study using the WHO pharmacovigilance database. J Affect Disord. 2021 Oct 24. doi:10.1016/j.jad.2021.10.041 • PubMed
>Highlights
>
>• Short half-life antidepressants are the most likely to cause withdrawal syndromes.
>
>• Women and adult patients are particularly at-risk.
>
>• Paroxetine and SNRIs should be avoided in at-risk patients.
Hey everyone. I want some ideas to create pharmacovigilance poster for college presentation. I have limited time,will u guys help me ?
Hi, I am a medical doctor that is currently working as a research coordinator(in heme/onc) within a major university here in the US (One of the top Universities in the US and the world), my ultimate goal is to work in pharmacovigilance and progress from there into a medical director role (I know it'll take a while). I have recently been offered a CRA position (in heme/onc) by a pretty big CRO. I am fairly new to the field with about 2 years of experience. With my goal to transition into a pharmacovigilance role, would taking a job as a CRA help me or should I stick to my job as a CRC. Any help would be greatly appreciated!
Quilichini JB, et al. Comparative effects of 15 antidepressants on the risk of withdrawal syndrome: A real-world study using the WHO pharmacovigilance database. J Affect Disord. 2021 Oct 24. doi.org/10.1016/j.jad.2021.10.041 • PubMed
>Highlights:
>
>• Short half-life antidepressants are the most likely to cause withdrawal syndromes.
>
>• Women and adult patients are particularly at-risk.
>
>• Paroxetine and SNRIs should be avoided in at-risk patients.
